Infusion medium delivery device and method with compressible or curved reservoir or conduit

ABSTRACT

A delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present invention is a Continuation-In-Part of U.S. patentapplication Ser. No. 11/588,847, filed Oct. 27, 2006 (attorney docketno. 0390), which is incorporated herein by reference in its entirety. Inaddition, the present invention relates to U.S. Provisional PatentApplication 60/839,832, filed Aug. 23, 2006, titled Infusion MediumDelivery Device And Method With Compressible Or Curved Reservoir OrConduit,” which is incorporated herein by reference in its entirety andfrom which a priority filing date is claimed. The present invention alsorelates to U.S. Patent Application 60/678,290, filed May 6, 2005 andU.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled“Infusion Device And Method With Disposable Portion,” each of which isincorporated herein by reference in its entirety. The present inventionalso relates to co-pending application No. 60/839,821, filed Aug. 23,2006, titled “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery” (attorney docket no. 047711-0381), co-pendingapplication No. 60/839,822, filed Aug. 23, 2006 titled “Infusion MediumDelivery Device And Method For Driving Plunger In Reservoir” (attorneydocket no. 047711-0382); co-pending application No. 60/839,840, filedAug. 23, 2006, titled “Infusion Medium Delivery System, Device AndMethod With Needle Inserter And Needle Inserter Device Method” (attorneydocket no. 047711-0384); and co-pending application No. 60/839,741,filed Aug. 23, 2006, titled “Infusion Pumps And Methods And DeliveryDevices And Methods With Same” (attorney docket no. 047711-0385), thecontents of each of which is incorporated herein by reference, in itsentirety. Embodiments of the present invention also relate to: (i) U.S.patent application Ser. No. 11/588,832, filed Oct. 27, 2006, entitled“Infusion Medium Delivery Device and Method with Drive Device forDriving Plunger in Reservoir” (attorney docket no. 047711.0387); (ii)U.S. patent application Ser. No. 11/588,875, filed Oct. 27, 2006,entitled “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery” (attorney docket no. 047711.0393); (iii) U.S.Provisional Patent Application Ser. No. 60/854,829, filed Oct. 27, 2006,entitled “Infusion Medium Delivery System, Device and Method with NeedleInserter and Needle Inserter Device and Method” (attorney docket no.047711.0401); and (iv) U.S. patent application Ser. No. 11/589,323,filed Aug. 23, 2006, entitled “Infusion Pumps and Methods and DeliveryDevices and Methods with Same” (attorney docket no. 047711.0398), thecontents of each of which are incorporated by reference herein, in theirentirety.

FIELD OF THE INVENTION

Embodiments of the present invention relate to an infusion mediumdelivery device for delivering an infusion medium to a patient-user,wherein the delivery device includes a base portion and a durableportion connectable to the base portion, and wherein the base portioncan be separated from the durable portion and disposed of after one ormore specified number of uses. The base portion supports a compressiblereservoir or conduit, while the durable portion supports a rotor ormoveable track that is operatively coupled to a drive device forselective compression of the reservoir or conduit, to drive fluid out ofthe reservoir. In further embodiments, the reservoir may comprise acurved channel in which a plunger head is moveable in response tomovement of a moveable track.

BACKGROUND OF THE INVENTION

Certain chronic diseases may be treated, according to modern medicaltechniques, by delivering a medication or other substance to apatient-user's body, either in a continuous manner or at particulartimes or time intervals within an overall time period. For example,diabetes is a chronic disease that is commonly treated by deliveringdefined amounts of insulin to the patient-user at appropriate times.Some common modes of providing an insulin therapy to a patient includedelivery of insulin through manually operated syringes and insulin pens.Other modern systems employ programmable pumps to deliver controlledamounts of insulin to a patient.

Pump type delivery devices have been configured in external devices(that connect to a patient-user) or implantable devices (to be implantedinside of a patient-user's body). External pump type delivery devicesinclude devices designed for use in a generally stationary location (forexample, in a hospital or clinic), and further devices configured forambulatory or portable use (to be carried by a patient-user). Examplesof some external pump type delivery devices are described in U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, titled “InfusionDevice And Method With Disposable Portion” and Published PCT ApplicationWO 01/70307 (PCT/US01/09139) titled “Exchangeable Electronic Cards ForInfusion Devices” (each of which is owned by the assignee of the presentinvention), Published PCT Application WO 04/030716 (PCT/US2003/028769)titled “Components And Methods For Patient Infusion Device,” PublishedPCT Application WO 04/030717 (PCT/US2003/029019) titled “DispenserComponents And Methods For Infusion Device,” U.S. patent applicationPublication No. 2005/0065760 titled “Method For Advising PatientsConcerning Doses Of Insulin,” and U.S. Pat. No. 6,589,229 titled“Wearable Self-Contained Drug Infusion Device,” each of which isincorporated herein by reference in its entirety.

External pump type delivery devices may be connected in fluid-flowcommunication to a patient-user, for example, through a suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the patient-user's skin and deliver an infusionmedium to the patient-user. Alternatively, the hollow tubing may beconnected directly to the patient-user as or through a cannula orthrough a set of micro-needles.

In contexts in which the hollow tubing is connected to the patient-userthrough a hollow needle that pierces the patient-user's skin, a manualinsertion of the needle into the patient-user can be somewhat traumaticto the patient-user. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the patient-user, whereby a needleis forced by a spring to quickly move from a retracted position into anextended position. Examples of insertion mechanisms that are built intoa delivery device are described in U.S. patent application Ser. No.11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method WithDisposable Portion” (assigned to the assignee of the present invention),which is incorporated herein by reference in its entirety. Otherexamples of insertion tools are described in U.S. patent applicationPublication No. 2002/0022855, titled “Insertion Device For An InsertionSet And Method Of Using The Same” (assigned to the assignee of thepresent invention), which is incorporated herein by reference in itsentirety. As the needle is moved into the extended position, the needleis quickly forced through the patient-user's skin in a single,relatively abrupt motion that can be less traumatic to a patient-user ascompared to a slower, manual insertion of a needle. However, in somecontexts, a controlled, slow insertion speed can be less traumatic tosome patients.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a patient-user, in that accuratedoses of insulin may be calculated and delivered automatically to apatient-user at any time during the day or night. Furthermore, when usedin conjunction with glucose sensors or monitors, insulin pumps may beautomatically controlled to provide appropriate doses of infusion mediumat appropriate times of need, based on sensed or monitored levels ofblood glucose.

Pump type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and doctors and patient-usersbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

Embodiments of the present invention relate to an infusion mediumdelivery device for delivering an infusion medium to a patient-user,wherein the delivery device includes a first (or durable) housingportion and a second (or disposable) housing portion that selectively,engage and disengage from each other, for example, by manual force. Oneor both of the first and second housing portions secures to thepatient-user. The disposable housing portion may be disposed of after ithas been in use for a prescribed period. Components that normally comeinto contact with a patient-user and/or with infusion media may besupported by the disposable housing portion for disposal after theprescribed use, while the durable housing portion supports othercomponents such as electronics for controlling the delivery of infusionmedia.

In some example embodiments, the disposable housing portion supports acompressible reservoir or conduit, while the durable housing portionsupports a rotor or moveable track that is operatively coupled to adrive device for selective compression of the reservoir or conduit, todrive fluid out of the reservoir or through the conduit. In furtherembodiments, the reservoir may comprise a curved channel in which aplunger head is moveable in response to movement of a moveable track.

According to an example embodiment, a delivery device includes first andsecond housing portions as described above and a rotatable rotor thatsupports at least one pad or roller for movement in an annular path withthe rotation of the rotor. In that embodiment, a conduit is supported bythe first housing portion and has a flexible portion arranged within atleast a portion of the annular path of the pad(s) or roller(s) to beengaged at locations along the annular path by the pad(s) or roller(s)when the second housing portion and the first housing portion areengaged. The flexible portion of the conduit is resiliently collapsibleat the locations of engagement of the pad(s) or roller(s) to provide apumping action as the rotor rotates the pad(s) or roller(s) along theannular path while the second housing portion and first housing portionare engaged. Also, the conduit is connectable in fluid flowcommunication with an injection site.

In the above-described example embodiment, the delivery device furtherincludes a reservoir that has an interior volume for containing a fluid.The interior volume of the reservoir is provided in fluid flowcommunication with the conduit. In addition, a drive device is supportedby the second housing portion and is operatively coupled to the rotorfor selectively rotating the rotor.

In the same or a further example embodiment, the rotatable rotor issupported for rotation by the second housing portion. The rotor may bedisposed within a recess in a wall of the second housing portion.

In the same or a further example embodiment, the second housing portionhas a housing structure with an internal volume and the rotor issupported by the second housing portion, but is disposed outside of theinternal volume of the second housing portion. In such an embodiment,the delivery device includes a rotor shaft that has a longitudinal axis.The rotor shaft is coupled to the rotor and extends into the internalvolume of the second housing portion and is operatively coupled to thedrive device. The rotor shaft may extend through an aperture in a wallof the second housing portion. A seal may be disposed around theaperture in the wall of the second housing portion.

In one example embodiment, the rotor comprises at least two wheels,including a drive wheel that is operatively coupled to a drive device toreceive rotational drive force. In that example embodiment, a belt-likestructure extends in an annular path around the two (or more) wheels,and at least one pad or roller is supported on the belt. Alternatively,the rotor may include a rotary wheel with the pad(s) or roller(s)supported by the rotary wheel. For example, the rotary wheel may besupported for rotation about a first axis of rotation with at least onerotatable roller supported for rotation on the rotary wheel about asecond axis of rotation that is orthogonal to the first axis ofrotation.

In any of the above-described embodiments, the flexible portion of theconduit may be supported on a flat support surface. Alternatively, theflexible portion of the conduit may be supported on a curved supportsurface. In any of the above-described embodiments, the reservoir mayinclude a rigid container structure and the support surface may be asurface of the reservoir.

In a further example embodiment, the flexible portion of the conduitthat is arranged within at least a portion of the annular path of thepad(s) or roller(s) includes a conduit portion arranged in at least apartial coil around a generally annular path. In such further exampleembodiment, the rotor is rotatable about a first axis of rotation andone or more rollers may be supported on the rotor, with each rollersupported for rotation about a respective axis of rotation that istransverse to the first axis of rotation and/or along a path that alignswith the annular path of the conduit, when the first and second housingportions are engaged.

Further embodiments relate to methods of making a delivery device. Inone example embodiment, a method includes providing a first housingportion and providing a second housing portion configured to selectivelyengage with and disengage from the first housing portion. The methodaccording to that example embodiment further includes supporting arotatable rotor for rotation, where the rotor has at least one pad orroller for movement in an annular path with the rotation of the rotor.The method according to that example embodiment also includes providinga conduit that has a flexible portion and coupling an interior volume ofa reservoir in fluid flow communication with the conduit, where theinterior volume of the reservoir is for containing a fluid.

The above example method embodiment further includes supporting theflexible portion of the conduit on the first housing portion andarranging the flexible portion of the conduit within at least a portionof the annular path of the pad(s) or roller(s) to be engaged atlocations along the annular path by the pad(s) or roller(s) when thesecond housing portion and the first housing portion are engaged. Theflexible portion of the conduit is resiliently collapsible at thelocations of engagement of the pad(s) or roller(s) to provide a pumpingaction as the rotor rotates while the first and second housing portionsare engaged. In addition, the conduit is connectable in fluid flowcommunication with an injection site.

In addition, the above example method embodiment further includessupporting a drive device on the second housing portion and operativelycoupling the drive device to the rotor for selectively rotating therotor to provide the pumping action while the first and second housingportions are engaged. In the above example embodiment, supporting arotatable rotor may include supporting at least two wheels and extendinga belt-like structure in an annular path around the at least two wheels,and wherein the at least one pad or roller is supported on the belt.Alternatively, supporting a rotatable rotor may include supporting arotary wheel, where the pad(s) or roller(s) is(are) supported by therotary wheel. In yet a further method embodiment, supporting a rotatablerotor includes supporting a rotary wheel for rotation about a first axisof rotation, and at least one rotatable roller is supported for rotationon the rotary wheel about a second axis of rotation that is orthogonalto the first axis of rotation.

A further example method embodiment includes arranging a portion of theconduit in at least a partial coil around a generally annular path. Thatfurther example method embodiment also includes supporting a rotor forrotation about a first axis and supporting one or more rollers on therotor, each for rotation about a respective axis of rotation that istransverse to the first axis of rotation and/or along a path that alignswith the annular path of the conduit, when the first and second housingportions are engaged.

According to another example embodiment, a delivery device includesfirst and second housing portions as described above and a compressiblereservoir located in the first housing portion. The reservoir has aninterior volume for containing a fluid and an outlet connectable influid flow communication with an injection site. The interior volume ofthe reservoir is compressible to reduce the interior volume and increasefluid pressure within the interior volume to drive fluid from theinterior volume to the injection site. A compression mechanism isoperable on the reservoir and a drive device is supported by the secondhousing portion and operatively connectable to at least one of thereservoir and the compression mechanism when the first and secondhousing portions are engaged, to selectively cause relative movementbetween the reservoir and compression mechanism for selectivecompression of the reservoir.

A delivery device according to the above embodiment may further includea moveable track operatively coupled to the drive device to beselectively moved along a track path. In such an embodiment, thecompression mechanism includes at least one roller or pad supported bythe moveable track for engaging and compressing the reservoir as thetrack is moved along the track path.

In a delivery device according to one example of the above embodiment,the moveable track may be connected to the reservoir to move thereservoir as the track is moved along the track path. In such an exampleembodiment, the compression mechanism includes a pair of compressionsurfaces between which a portion of the reservoir is moved as the trackis moved along the track path. The compression surfaces impart acompression force on the reservoir as the portion of the reservoir ismoved between the compression surfaces. The pair of compression surfacesmay include a pair of rollers.

In a delivery device according another example of the above embodiment,the compression mechanism comprises a plunger head supported formovement within the interior volume of the reservoir. In that exampleembodiment, the delivery device further includes a moveable trackoperatively coupled to a drive device to be selectively moved along atrack path. The moveable track is operatively connectable to the plungerhead to move the plunger head within the reservoir when the track ismoved along the track path and when the first and second housingportions are engaged. In a further example of that example embodiment,the reservoir includes a curved channel having a radius of curvature andthe track has a radius of curvature approximating the radius ofcurvature of the curved channel.

In any of the above-described embodiments, the delivery device mayfurther include electrical control circuitry contained in the secondhousing portion. The electrical control circuitry controls the drivedevice for delivery of infusion media from the reservoir to the userwhen the second housing portion and the first housing portion areengaged.

Also in any of the above describe embodiments, one of the first andsecond housing portions may include a base portion that has a bottomsurface and an adhesive material on the bottom surface for securing thathousing portion to the skin of the user.

According to another example embodiment, the delivery device may includea moveable track coupled to one of the compression mechanism or thereservoir. In that example embodiment, the drive device is operativelycoupled to the moveable track for moving the moveable track and one ofthe compression mechanism or the reservoir relative to the other of thecompression mechanism and reservoir. In that example embodiment, alinkage structure may be provided for operatively coupling the drivedevice to the moveable track, to transfer drive force from the drivedevice to the moveable track.

Further embodiments of the present invention relate to methods of makingdelivery devices. According to one embodiment, a method includesproviding a first housing portion and providing a second housing portionconfigured to selectively engage with and disengage from the firsthousing portion. That method embodiment further includes supporting acompressible reservoir on the first housing portion. The reservoir hasan interior volume for containing a fluid and an outlet connectable influid flow communication with an injection site. The reservoir iscompressible to reduce the interior volume and increase fluid pressurewithin the interior volume to drive fluid from the interior volume tothe injection site.

That method embodiment further includes supporting a compressionmechanism in a position to selectively compress the reservoir andsupporting a drive device supported on the second housing portion in aposition to operatively connect to at least one of the reservoir and thecompression mechanism when the first and second housing portions areengaged, to selectively cause relative movement between the reservoirand compression mechanism for selective compression of the reservoir.

According to one example, the above method embodiment further includesoperatively coupling a moveable track to the drive device to beselectively moved along a track path. In such example embodiment,supporting a compression mechanism comprises supporting at least oneroller or pad on the moveable track for engaging and compressing thereservoir as the track is moved along the track path.

According to another example, the above method embodiment also furtherincludes operatively coupling a moveable track to the drive device to beselectively moved along a track path. However this other exampleembodiment includes connecting the moveable track to the reservoir tomove the reservoir as the track is moved along the track path. Accordingto this other example embodiment, supporting a compression mechanismcomprises supporting a pair of compression surfaces between which aportion of the reservoir is moved as the track is moved along the trackpath. The compression surfaces are supported in a position to impart acompression force on the reservoir as the portion of the reservoir ismoved between the compression surfaces. In such an embodiment,supporting a pair of compression surfaces may include supporting a pairof rollers on the first housing portion.

In another example method embodiment, supporting a compression mechanismincludes supporting a plunger head for movement within the interiorvolume of the reservoir. According to such other example embodiment, themethod further includes operatively coupling a moveable track to thedrive device to be selectively moved along a track path and operativelycoupling the moveable track to the plunger head to move the plunger headwithin the reservoir when the track is moved along the track path andwhen the first and second housing portions are engaged. In such anembodiment, the reservoir may include a curved channel having a radiusof curvature and the track may have a radius of curvature approximatingthe radius of curvature of the curved channel.

Any of the above-described method embodiments may further includecontaining electrical control circuitry in the second housing portion,where the electrical control circuitry controls the drive device fordelivery of infusion media from the reservoir to the user when thesecond housing portion and the first housing portion are engaged. Also,any of the above-described embodiments may include providing one of thefirst and second housing portions with a base portion having a bottomsurface and an adhesive material on the bottom surface for securing thathousing portion to the skin of the user.

Another example method embodiment may include operatively coupling amoveable track to one of the compression mechanism or the reservoir.This other example embodiment also includes operatively coupling thedrive device to the moveable track for moving the moveable track and oneof the compression mechanism or the reservoir relative to the other ofthe compression mechanism and reservoir. This other example embodimentmay also include operatively coupling linkage structure to the drivedevice and to the moveable track, to transfer drive force from the drivedevice to the moveable track.

According to another example embodiment, a delivery device includesfirst and second housing portions as described above and a reservoirlocated in the first housing portion. The reservoir has a selectivelyvariable, first interior volume for containing a fluid and an outletconnectable in fluid flow communication with the first interior volumeand an injection site. The delivery device according to this exampleembodiment also includes a volume varying mechanism defines a boarder ofthe first interior volume and is supported for motion in a curved pathto selectively vary the first interior volume of the reservoir, toselectively reduce the first interior volume and increase fluid pressurewithin the interior volume to drive fluid from the interior volume tothe injection site. The delivery device according to this exampleembodiment also includes a drive device supported by the second housingportion and operatively connectable to the volume varying mechanism whenthe first and second housing portions are engaged, to selectively drivethe volume varying mechanism in the curved path of motion.

In the above-described example embodiment, the volume varying mechanismmay include a rotary arm supported for rotation about a rotary axiswithin the reservoir. In such an embodiment, the first interior volumeis located on one side of the rotary arm. In addition, a drive linkagemay be operatively coupled to the drive device and the rotary arm, forconveying drive force from the drive device to the rotary arm when thefirst and second housing portions are engaged.

In one example embodiment, the drive linkage includes a shaft extendingfrom one of the first and second housing portions and a receptaclelocated on the other of the first and second housing portions, where theshaft and receptacle each have a mating shape that engages and mateswith the mating shape on the other of the shaft and receptacle when thefirst and second housing portions are engaged. In such an exampleembodiment, one of the shaft and the receptacle is operatively coupledto the drive device for rotation by the drive device and the other ofthe shaft and the receptacle is operatively coupled to the rotary arm toselectively rotate the rotary arm relative to the reservoir, toselectively vary the first interior volume of the reservoir.

In a further example embodiment, the drive linkage includes a shaft thatextends from the second housing portion and is operatively coupled tothe drive device for rotation by the drive device. In such furtherexample embodiment, a receptacle is coupled to the rotary arm on thefirst housing portion. The shaft and the receptacle each have a matingshape that engages and mates with the mating shape on the other of theshaft and receptacle when the first and second housing portions areengaged.

In any of the above-described embodiments, the reservoir may have adisk-shaped interior and the first interior volume of the reservoir is aportion of the disk-shaped interior. In that embodiment, the disk-shapedinterior may have a central axis and the rotary arm may be supported forrotation about the central axis of the disk-shaped interior. The rotaryarm may have one end supported at the central axis of the disk shapedinterior.

The reservoir may include a pair of walls within the disk-shapedinterior, defining a wedge-shaped volume that is outside of the firstinterior volume of the reservoir. In such an embodiment, the reservoiroutlet may be provided through one of the walls defining thewedge-shaped volume. Also, such an embodiment may further include an airvent through one of the walls defining the wedge-shaped volume andprovided in air-flow communication with the disk-shaped interior of thereservoir.

In any of the above-described embodiments that have a disk-shapedreservoir interior, an air vent provided in air-flow communication withthe disk-shaped interior of the reservoir. In such an embodiment, theair vent may be located in a wall of the reservoir on a side of therotary arm opposite to the side of the first interior volume. Also inany of the above-described embodiments, the reservoir may have anoverall interior volume in which the first interior volume is included;and the delivery device may further include an air vent provided inair-flow communication with the interior volume of the reservoir.

Further embodiments of the present invention relate to methods of makinga delivery device for delivering a fluidic medium to or from a patient.In one embodiment, the method includes providing a first housing portionand providing a second housing portion configured to selectively engagewith and disengage from the first housing portion. That methodembodiment further includes providing a reservoir in the first housingportion. The reservoir has a first, selectively variable, interiorvolume for containing a fluid and an outlet connectable in fluid flowcommunication with the first interior volume and an injection site.

The above-described method embodiment further includes supporting avolume varying mechanism adjacent a boarder of the first interior volumefor motion in a curved path to selectively vary the first interiorvolume of the reservoir, to selectively reduce the first interior volumeand increase fluid pressure within the interior volume to drive fluidfrom the interior volume to the injection site. In addition, theabove-described method embodiment includes supporting a drive device onthe second housing portion in a position to operatively connect to thevolume varying mechanism when the first and second housing portions areengaged, to selectively drive the volume varying mechanism in the curvedpath of motion.

In the above-described method embodiment, supporting a volume varyingmechanism may include supporting a rotary arm for rotation about arotary axis within the reservoir, wherein the first interior volume islocated on one side of the rotary arm. Such an embodiment may furtherinclude operatively coupling a drive linkage to the drive device and therotary arm for conveying drive force from the drive device to the rotaryarm when the first and second housing portions are engaged.

In one example, operatively coupling a drive linkage includes extendinga shaft from one of the first and second housing portions and providinga receptacle on the other of the first and second housing portions. Insuch an embodiment, the shaft and receptacle each have a mating shapethat engages and mates with the mating shape on the other of the shaftand receptacle when the first and second housing portions are engaged.Such an embodiment further includes operatively coupling one of theshaft and the receptacle to the drive device for rotation by the drivedevice and operatively coupling the other of the shaft and thereceptacle to the rotary arm to selectively rotate the rotary armrelative to the reservoir, to selectively vary the first interior volumeof the reservoir.

In another example, operatively coupling a drive linkage includesoperatively coupling a shaft to the drive device for rotation by thedrive device and extending the shaft from the second housing portion.This embodiment further includes coupling a receptacle to the rotary armon the first housing portion. The shaft and receptacle each have amating shape that engages and mates with the mating shape on the otherof the shaft and receptacle when the first and second housing portionsare engaged.

In any of the above-described method embodiments, the reservoir may havea disk-shaped interior and the first interior volume of the reservoirmay be a portion of the disk-shaped interior. In such embodiments, thedisk-shaped interior may have a central axis and the method may includesupporting a rotary arm for rotation about the central axis of thedisk-shaped interior. Such an embodiment may include supporting one endof the rotary arm at the central axis of the disk shaped interior.

Any of the above-described embodiments may include providing an air ventin air-flow communication with the interior of the reservoir. Such anembodiment may include providing an air vent in a wall of the reservoiron a side of the rotary arm opposite to the side of the first interiorvolume. These and other embodiments of the present invention aredescribed below, with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generalized diagram of a delivery system in relation to ahuman patient-user.

FIG. 2 is a perspective view of a delivery device according to anembodiment of the invention.

FIG. 3 is a perspective view of a durable portion and a disposableportion of the delivery device of FIG. 2, with the durable portionseparated from the disposable portion.

FIG. 4 is a schematic, cross-sectional view of a delivery deviceaccording to an embodiment of the invention.

FIG. 5 is a schematic, cross-sectional view of part of a durable housingportion of the embodiment of FIG. 4.

FIG. 6 is a schematic view of another reservoir, conduit and rotorarrangement that may be employed in a delivery device of FIG. 4, inplace of the reservoir, conduit and rotor arrangement shown in FIG. 4.

FIG. 7 is a side view of a delivery device according to anotherembodiment of the invention.

FIG. 8 shows a top view of the durable housing portion of the deliverydevice of FIG. 7.

FIG. 9 shows a side cross-section view of the durable housing portion ofthe delivery device of FIG. 7.

FIG. 10 shows a bottom view of the disposable housing portion of thedelivery device of FIG. 7.

FIG. 11 shows a side cross-section view of the disposable housingportion of the delivery device of FIG. 7.

FIG. 12 shows another side view of the delivery device of FIG. 7, withthe disposable and durable housing portions separated.

FIG. 13 is a side cross section view of another embodiment of a deliverydevice, with the disposable and durable housing portions separated.

FIG. 14 is a schematic cross section view of a delivery device accordingto another embodiment of the invention.

FIG. 15 is a schematic, cross section view of part of another disposablehousing portion for a delivery device of FIG. 14, that may be used inplace of the disposable housing portion shown in FIG. 14.

FIG. 16 is a schematic cross section view of a delivery device accordingto another embodiment of the invention.

FIG. 17 is a side view of a plunger head and moveable track for adelivery device of FIG. 16.

FIG. 18 is a schematic cross section view of a disposable portion of adelivery device according to another embodiment of the presentinvention.

FIG. 19 is a perspective view of a delivery device including adisposable portion of FIG. 18 and a durable portion in a separatedrelation.

FIG. 20 is a cross-sectional view of a portion of a delivery deviceaccording to a further embodiment of the invention.

FIG. 21 is a partial cross-sectional view of a cam follower adjacent aninlet of the embodiment of FIG. 20.

FIG. 22 is a partial cross-sectional view of a cam follower adjacent anoutlet of the embodiment of FIG. 20.

FIG. 23 is a perspective view of a cam housing according to theembodiment of FIG. 20.

FIGS. 24 a-24 d are schematic views of various escapement wheelarrangements and components thereof that may be used with drive devicesin various embodiments described herein.

FIG. 25 shows a schematic side view of an arrangement of a durablehousing portion and a disposable housing portion of a delivery systemaccording to an embodiment of the invention consistent with theembodiment of FIG. 3.

FIG. 26 shows a schematic side view of an arrangement of a durablehousing portion and a disposable housing portion of a delivery systemaccording to another embodiment of the invention.

FIG. 27 shows a partially exploded view of a delivery device accordingto an embodiment of the invention.

FIG. 28 shows a schematic top view of an arrangement of a durablehousing portion and a disposable housing portion of a delivery systemaccording to an embodiment of the invention.

FIG. 29 shows a schematic top view of an arrangement of a durablehousing portion and a disposable housing portion of a delivery systemaccording to another embodiment of the invention.

FIGS. 30-32 each show a perspective view of a connection arrangement fora disposable housing portion and an injection site module.

FIGS. 33 and 34 each show a perspective view of another connectionarrangement for a disposable housing portion and an injection sitemodule.

FIGS. 35-37 each show a perspective view of yet another connectionarrangement for a disposable housing portion and an injection sitemodule.

DETAILED DESCRIPTION

The present invention relates, generally, to delivery devices, systemsand methods for delivering an infusion medium, such as a drug, to arecipient, such as a medical patient-user. In particular embodiments, adelivery device includes first and second housing portions (referred toherein as a durable housing portion and a disposable housing portion,respectively) that are configured to engage and attach to each other foroperation. The disposable housing portion may contain or otherwisesupport an infusion medium reservoir and other components that come intocontact with the infusion medium and/or the patient-user duringoperation. The disposable housing portion may be disengaged andseparated from the durable housing portion, such that the disposablehousing portion may be readily disposed of after it has been in use fora period of time, or after one or a prescribed number of uses. Afterdisengagement and separation from a disposable housing portion, thedurable housing portion may be engaged and operatively connected toanother disposable housing portion (such as a new, refurbished,user-filled, prefilled, refilled or re-manufactured disposable housingportion) for further operation. The durable housing portion may containor otherwise support components that do not come into contact with theinfusion medium or the patient-user during normal operation of thedelivery device, including, but not limited to, a drive device, drivelinkage, electronic circuits and, in some embodiments, a power source.

Delivery device embodiments described herein include a compressiblereservoir or conduit that is acted upon by a compression structure. Arotor or moveable track provides relative motion between the compressionstructure and the reservoir or conduit, to selectively compress thereservoir or conduit and selectively drive fluid out of the reservoir toan injection site. Embodiments described herein employ various mannersof supporting a drive device with the durable housing portion fordriving the rotor or moveable track, while supporting a flexiblereservoir or conduit with the disposable housing portion, and to allowoperative connection of the drive device and/or rotor or track to theflexible reservoir or conduit when the durable housing portion anddisposable housing portion are engaged, yet also allow the durablehousing portion and disposable housing portion to be disengaged andseparated from each other, for replacement or servicing of thedisposable housing portion.

For example, various embodiments employ a peristaltic pump arrangement,in which a rotor imparts a compression force on a flexible conduit, todraw fluid from the reservoir, through the conduit, when the disposablehousing portion and durable housing portion are engaged. Furtherembodiments employ a flexible reservoir structure that is compressed bya compression structure, upon relative movement between the compressionstructure and the flexible reservoir. In further embodiments, thereservoir may comprise a curved channel in which a plunger head ismoveable in response to movement of a moveable track. Various structuresare described herein that allow the reservoir and certain othercomponents to be supported by a disposable housing portion, while adrive device and other components may be supported in the durablehousing portion for operable connection with the reservoir when thedisposable housing portion and durable housing portion are engaged. Suchembodiments may be configured to provide a reliable, user-friendlymechanism to secure the delivery device to a patient-user for deliveryof fluidic an infusion medium to the patient-user and also provide acost effective manner of replacing or servicing depleted or usedreservoirs.

While embodiments of the present invention are described herein withreference to an insulin delivery example for treating diabetes, otherembodiments of the invention may be employed for delivering otherinfusion media to a patient-user for other purposes. For example,further embodiments of the invention may be employed for deliveringother types of drugs to treat diseases or medical conditions other thandiabetes, including, but not limited to drugs for treating pain orcertain types of cancers, pulmonary disorders or HIV. Furtherembodiments may be employed for delivering media other than drugs,including, but not limited to, nutritional media including nutritionalsupplements, dyes or other tracing media, saline or other hydrationmedia, or the like. Also, while embodiments of the present invention aredescribed herein for delivering or infusing an infusion medium to apatient-user, other embodiments may be configured to draw a medium froma patient-user.

Furthermore, while embodiments of the present invention refer to thehousing portions of disclosed delivery devices as disposable or durable,and may be configured to allow the disposable housing portion to bedisposed of and replaced in an economically efficient manner, it will beunderstood that, in further embodiments, the disposable housing portionembodiments described herein may be re-used and need not be disposed of.Similarly, the durable housing portion embodiments described herein maybe disposed of after one or more uses, if desired. However, embodimentsare configured to allow certain components (for example, those thatcontact the infusion medium or the patient-user during operation) to behoused in a first housing portion that may be readily disposable, whileother components (for example, those that do not contact the infusionmedium or the patient-user during operation and that have a replacementcost that is of a relatively significant level) may be housed in asecond housing portion that may be re-used with one or more new,refurbished, user-filled, prefilled, refilled or re-manufactureddisposable first housing portions.

A generalized representation of an infusion medium delivery system 10 isshown in FIG. 1, wherein the system includes a delivery device 12configured according to an embodiment of the invention described herein.The system 10 may also include other components coupled forcommunication with the delivery device 12, including, but not limitedto, a sensor or monitor 14, a command control device (CCD) 16 and acomputer 18. Each of the CCD 16, the sensor or monitor 14, the computer18 and the delivery device 12 may include receiver or transceiverelectronics that allow communication with other components of thesystem. The delivery device 12 may include electronics and software foranalyzing sensor data and for delivering an infusion medium according tosensed data and/or pre-programmed delivery routines. Some of theprocessing, delivery routine storage and control functions may becarried out by the CCD 16 and/or the computer 18, to allow the deliverydevice 12 to be made with more simplified electronics. However, in otherembodiments, the system 10 may comprise delivery device 12 that operateswithout any one or more of the other components of the system 10 shownin FIG. 1. Examples of the types of communications and/or controlcapabilities, as well as device feature sets and/or program options maybe found in U.S. patent application Ser. No. 10/445,477 filed May 27,2003, and entitled “External Infusion Device with Remote Programming,Bolus Estimator and/or Vibration Alarm Capabilities,” and U.S. patentapplication Ser. No. 10/429,385 filed May 5, 2003, and entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same,” U.S. patent application Ser. No. 09/813,660 filedMar. 21, 2001, and entitled “Control Tabs For Infusion Devices AndMethods Of Using The Same,” all of which are incorporated herein byreference in their entirety.

In the generalized system diagram of FIG. 1, the delivery device 12 andsensor or monitor 14 are secured to a patient-user 1. The locations atwhich those components are secured to the patient-user 1 in FIG. 1 areprovided only as a representative, non-limiting example. The deliverydevice 12 and sensor or monitor 14 may be secured at other locations onthe patient-user 1, and such locations may depend upon the type oftreatment to be administered by the system 10. Such other locations mayinclude, but are not limited to, other locations on the patient-user'sbody, locations on the patient-user's clothing, belt, suspenders,straps, purse, tote or other structure that may be carried by thepatient-user.

As described in further detail below, the delivery device 12 contains areservoir of an infusion medium and delivers the infusion medium, suchas, but not limited to an insulin formulation, into the patient-user'sbody in a controlled manner. Control instructions and/or data may becommunicated between the delivery device 12, the sensor or monitor 14,the CCD 16 and the computer 18. The delivery device 12 may be configuredto secure to the skin of a patient-user 1, in the manner of a patch, ata desired location on the patient-user. In such embodiments, it isdesirable that the delivery device 12 have relatively small dimensionsfor comfort and ability to conceal the device, for example, under agarment.

Examples of patch-like delivery devices are described in U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, which isincorporated herein, in its entirety. Delivery devices described in U.S.patent application Ser. No. 11/211,095 employ a reservoir structurehaving a moveable plunger for selectively driving fluid from thereservoir. An example of a patch-like delivery device 12 that employs aperistaltic pumping arrangement, instead of a reservoir-plungerarrangement is shown in FIGS. 2-5 herein. The delivery device 12 in FIG.2 includes a base housing portion 20 that, in some embodiments, may bedisposable after one or a number of specified uses, and a furtherhousing portion 22. For convenience, but without limitation, the baseportion 20 is referred to herein as a disposable housing portion ordisposable portion, while the further housing portion 22 is referred toherein as a durable housing portion or durable portion. However, asnoted above, in operation, either or both housing portions 20 or 22 maybe disposed of or re-used, depending upon the context of use.

The disposable housing portion 20 may support structural elements thatordinarily contact the patient-user's skin or the infusion medium,during operation of the delivery device 12. On the other hand, thedurable housing portion 22 may support elements (including electronics,motor components, linkage components, and the like) that do notordinarily contact the patient-user or the infusion medium duringoperation of the delivery device 12. Thus, elements in the durablehousing portion 22 of the delivery device 12 are typically notcontaminated from contact with the patient-user or the infusion mediumduring normal operation of the delivery device 12.

In the illustrated embodiment, the disposable housing portion 20 of thedelivery device 12 comprises a base 21 that includes or otherwisesupports a reservoir retaining portion 24 that houses a reservoir. Thedurable housing portion 22 may comprise a housing that secures onto thebase 21 adjacent the reservoir retaining portion 24. The durable housingportion 22 may house a suitable drive device, such as an electricallyoperated motor (not shown in FIG. 2), and drive linkage components (notshown in FIG. 2) for driving fluid out of the reservoir. The durablehousing portion 22 also may house suitable control electronics (notshown in FIG. 2) for controlling the operation of the drive device todrive fluid from the reservoir in a controlled manner. Furtherembodiments may include other electronics within the durable housingportion 22, such as, but not limited to communication electronics (notshown in FIG. 2) for communicating with the sensor or monitor 14, theCCD 16, the computer 18 and/or other components of the system 10 shownin FIG. 1.

The base 21 of the disposable housing portion 20 has a bottom surface(facing downward and into the page in FIGS. 2 and 3) that is configuredto secure to a patient-user's skin at a desired location on thepatient-user. A suitable adhesive may be employed at the interfacebetween the bottom surface of the base 21 and the patient-user's skin,to adhere the base 21 to the patient-user's skin. The adhesive may beprovided on the bottom surface of the base 21, with a peelable coverlayer 23 covering the adhesive material. In this manner, a patient-usermay peel off the cover layer 23 to expose the adhesive material and thenplace the adhesive side of the base 21 against the patient-user's skin.

The disposable portion 20 may include a button or other operator 25 foroperating a needle inserter device located within the reservoirretaining portion 24. Alternatively, or in addition, reference number 25may represent an opening, through which an external needle inserterdevice may operate. Alternatively, or in addition to an operator oropening 25, the needle inserter device may be activated, through awireless link, from an external controller, such as the CCD 16, sensoror monitor 14 or computer 18. For such embodiments, the CCD 16, sensoror monitor 14 or computer 18 includes a wireless signal transmitter,while the delivery device includes a receiver for receiving a wirelessactuation signal and an electronic actuator that is controlled toactuate the needle inserter device, upon receipt of an actuation signalfrom the CCD 16, sensor or monitor 14 or computer 18. Examples ofsuitable needle inserter devices are described in U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, and U.S. PatentApplication No. 60/839,840, filed Aug. 23, 2006, titled “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device Method” (attorney docket no. 047711-0384), each of whichis incorporated herein by reference in its entirety. Otherneedle/cannula insertion tools may be used (or modified for use) toinsert a needle and/or cannula, such as for example U.S. patentapplication Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled “AutoInsertion Device For Silhouette Or Similar Products,” and/or U.S. patentapplication Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled“Insertion Device For Insertion Set and Method of Using the Same,” bothof which are incorporated herein by reference in their entirety.Alternatively, the reservoir retaining portion may include a suitableopening or port for connecting one end of a hollow tube to thereservoir, while the other end of the hollow tube is connected to ahollow needle for piercing the patient-user's skin and conveying theinfusion medium from the reservoir into the patient-user, for example,as described with reference to FIG. 2 of U.S. patent application Ser.No. 11/211,095, filed Aug. 23, 2005.

The durable housing portion 22 of the delivery device 12 includes ahousing shell configured to mate with and secure to the disposablehousing portion 20. The durable housing portion 22 and disposablehousing portion 20 may be provided with correspondingly shaped grooves,notches, tabs or other suitable features that allow the two parts toeasily snap together, by manually pressing the two portions together ina manner well known in the mechanical arts. In a similar manner, thedurable housing portion 22 and disposable housing portion 20 may beseparated from each other by manually applying sufficient force tounsnap the two parts from each other. In further embodiments, a suitableseal, such as an annular seal, may be placed along the peripheral edgeof the disposable housing portion 20 and/or the durable housing portion22, so as to provide a liquid, hermetic, or air-tight seal between thedisposable housing portion 20 and the durable housing portion 22.

The durable housing portion 22 and disposable housing portion 20 may bemade of suitably rigid materials that maintain their shape, yet providesufficient flexibility and resilience to effectively snap together andapart, as described above. The base 21 material may be selected forsuitable compatibility with the patient-user's skin. For example, thedisposable housing portion 20 and the durable housing portion 22 of thedelivery device 12 may be made of any suitable plastic, metal, compositematerial or the like. The disposable housing portion 20 may be made ofthe same type of material or a different material relative to thedurable housing portion 22. The disposable and durable housing portionsmay be manufactured by injection molding or other molding processes,machining processes or combinations thereof.

The base 21 may be made of a relatively flexible material, such as aflexible silicone, plastic, rubber, synthetic rubber or the like. Byforming the base 21 of a material capable of flexing with thepatient-user's skin, a greater level of patient-user comfort may beachieved when the base is secured to the patient-user's skin. Also, aflexible base 21 can result in an increase in the site options on thepatient-user's body at which the base 21 may be secured.

The disposable housing portion 20 and/or the durable housing portion 22may include an internal sensor (not shown in FIGS. 2 and 3) forconnection to a patient-user, for example, through a needle (not shownin FIGS. 2 and 3) for piercing a patient-user's skin when the disposablehousing portion 20 is secured to a patient-user's skin. In suchembodiments, a suitable aperture (not shown in FIGS. 2 and 3) may beformed in the base 21, to allow the passage of the sensor needle, whenthe sensor needle is extended to pierce a patient-user's skin.Alternatively, the durable housing portion 20 of the delivery device 12may be connected to an external sensor 14, through a sensor lead, asdescribed with respect to FIG. 2 of U.S. patent application Ser. No.11/211,095, filed Aug. 23, 2005. The sensor may comprise any suitablebiological sensing device, depending upon the nature of the treatment tobe administered by the delivery device 12. For example, in the contextof delivering insulin to a diabetes patient-user, the sensor 14 maycomprise a blood glucose sensor. Alternatively, or in addition, one ormore environmental sensing devices may be included in or on the deliverydevice 12, for sensing one or more environmental conditions. In furtheralternatives, the sensor may be included with as a part or along sidethe infusion cannula and/or needle, such as for example as shown in U.S.patent Ser. No. 11/149,119 filed Jun. 8, 2005, and entitled “DualInsertion Set,” which is incorporated herein by reference in itsentirety.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable portion 20, while durable elements may be arrangedwithin a separable durable portion 22. In this regard, after one (or aprescribed number) of uses of the delivery device 12, the disposableportion 20 may be separated from the durable portion 22, so that thedisposable portion 20 may be disposed of in a proper manner. The durableportion 22 may, then, be mated with a new, refurbished, user-filled,prefilled, refilled or re-manufactured disposable portion 20 for furtherdelivery operation with a patient-user.

An example of a delivery device 12 having a disposable housing portion20 and a durable housing portion 22 is shown in FIG. 4. In theembodiment of FIG. 4, a reservoir 26 is located in the reservoirretaining portion 24 of the disposable housing portion 20. The reservoir26 may comprise a container having an internal volume for containing afluidic infusion medium, such as, but not limited to an insulinformulation. The reservoir 26 may be made of any material suitablycompatible with the infusion medium, including, but not limited tosuitable metal, plastic, ceramic, glass, composite material or the like.For example, the canister may be formed of a plastic material referredto as TOPAS (trademark of Ticona, a subsidiary of Celanese Corporation),such as described in U.S. patent application Ser. No. 11/100,188, filedApr. 5, 2005 (Publication No. 2005/0197626), the contents of which isincorporated herein in its entirety. Examples of needle/septumconnectors used in reservoirs can be found in U.S. patent applicationSer. No. 10/328,393 filed Dec. 22, 2003, and entitled “ReservoirConnector,” which is incorporated herein by reference in its entirety.In other alternatives, non-septum connectors for use with reservoirssuch as Luer locks, or the like may be used.

The reservoir 26 may be supported by the reservoir retaining portion 24of the disposable portion 20 in any suitable manner. For example, thereservoir 26 may be supported on a surface of the base 21 and held inplace by one or more projections, walls or other stop surfaces 28. Theprojections, walls or other stop surfaces 28 may be formed or molded onor otherwise connected in a fixed manner to the base 21 or otherstructure of the disposable housing portion 20, in locations adjacentand abutting one or more sides of the reservoir 26. As described below,in some embodiments, the reservoir 26 may be configured to be removableand replaceable with respect to the disposable housing portion 20. Inother embodiments, the reservoir 26 may be secured to the disposablehousing portion 20 in a manner intended to inhibit removal of thereservoir 26 from the disposable housing portion 20. For example, anadhesive material may be employed to adhere a surface of the reservoir26 to the base 21 or other structure of the disposable housing portion20.

In yet other embodiments, the reservoir 26 may be formed unitarily withthe reservoir retaining portion 24, for example, as a hollow chamberprovided within an otherwise solid portion of the reservoir retainingportion 24. In such embodiments, the hollow interior of the reservoirretaining portion 24 may be coated or otherwise lined with a suitablemetal, plastic, plastic, TOPAS (trademark of Ticona, a subsidiary ofCelanese Corporation), ceramic, glass, composite material or the like.Alternatively, or in addition, the retaining portion 24, itself, may bemade of a suitable metal, plastic, plastic, TOPAS (trademark of Ticona,a subsidiary of Celanese Corporation), ceramic, glass, compositematerial or the like.

In the embodiment shown in FIG. 4, the reservoir 26 has a generallyrectangular-cube shape. In other embodiments, the reservoir 26 may haveother shapes, including, but not limited to a disk or partial-diskshape, tube shape, curved tube shape or other shape that maximizes theinternal volume of the reservoir, yet allows the dimensions of thereservoir retaining portion 24 to be minimized. As described below, insome embodiments, the reservoir 26 has a support surface 27 that may beformed as a flat surface (FIG. 4) or a curved surface (FIG. 6) forsupporting a flexible tube against the action of a peristaltic pumprotor.

The reservoir 26 has an outlet port 30, through which the infusionmedium contained within the interior of the reservoir 26 may becommunicated out of the reservoir. The outlet port 30 is open to theinterior of the reservoir 26 and may include suitable tube-connectionstructure. A tube-shaped conduit 32 having an internal fluid flow pathis connected, at a first end, in fluid-flow communication with theoutlet port 30. The conduit 32 may be made of any suitable material,including, but not limited to silicone or other plastic, metal, ceramicor composite material. At least a portion 33 of the length of theconduit 32 is made of a resilient, flexible material, such as, but notlimited to a silicone or other plastic material suitable for repeatedcontact with pads or rollers of a peristaltic rotor, as described below,to repeatedly compress and return the fluid flow path within the lengthportion 33 of the conduit 32. In some embodiments, the entire length ofthe conduit 32 is made of the resilient, flexible material.

A second end of the conduit 32 is connected in fluid flow communicationwith an injection site 35 located on the disposable housing portion 20.The injection site 35 may comprise an insertion mechanism to assist theinsertion of a needle or cannula into the patient-user and connection ofthe needle or cannula in flow communication with the conduit 32.Examples of such insertion mechanisms that are built into a deliverydevice are described in U.S. patent application Ser. No. 11/211,095,filed Aug. 23, 2005, titled “Infusion Device And Method With DisposablePortion” (assigned to the assignee of the present invention), which isincorporated herein by reference in its entirety. Other needle/cannulainsertion tools may be used (or modified for use) to insert a needleand/or cannula, such as for example U.S. patent application Ser. No.10/389,132 filed Mar. 14, 2003, and entitled “Auto Insertion Device ForSilhouette Or Similar Products,” and/or U.S. patent application Ser. No.10/314,653 filed Dec. 9, 2002, and entitled “Insertion Device ForInsertion Set and Method of Using the Same,” both of which areincorporated herein by reference in their entirety.

In the embodiment shown in FIG. 4, the length portion 33 of the conduit32 is supported on a surface 27 of the reservoir 26, at a locationarranged to be contacted and compressed by one or more pads or rollersof a peristaltic rotor, when the durable housing portion 22 is engagedwith the disposable housing portion 20. The conduit support surface 27in FIG. 4 is a generally flat, outer surface of the reservoir 26. Inother embodiments, such as shown in FIG. 6, the conduit support surfacemay comprise a curved surface, for increased length. While embodimentsshown in FIGS. 4 and 6 show the conduit support surface 27 as an outersurface of the reservoir 26, in other embodiments, the conduit supportsurface may comprise a flat or curved surface of a wall or otherstructural portion of the disposable housing portion 20.

A rotor 36 for a peristaltic pump arrangement is supported by thedurable housing portion 22. In the embodiment of FIG. 4, the rotor 36comprises first and second wheels 38 and 39, supported for rotationabout their central axes. A belt, ribbon, chain or similar structure 40extends in an annular path, around a portion of the outer peripheralsurface of each of the wheels 38 and 39 and has extends along agenerally flat path for the length between the wheels 38 and 39. Inother embodiments, the belt 40 may extend in an annular path around morethan two wheels 38 and 39. In the illustrated embodiment, both wheels 38and 39 are supported for rotation, while one of the wheels 38 isoperatively connected to a drive device for driving the belt 40 aroundits annular path. In other embodiments, only one wheel (the drive wheel38 that operatively connects to a drive device) may be supported forrotation, while the other wheel 39 may be non-rotating and provide aguide surface over which the belt 40 may slide, as the belt is driven.

The belt 40 has at least one (preferably a plurality) of pads or rollers42 extending from the outer perimeter of the annular path of the belt.The pads or rollers 42 may comprise projections or nubs, rotatable wheelstructures or the like on the outer peripheral surface of the belt. Thewheels 38 and 39 are positioned on the durable housing portion, suchthat a generally flat length of the belt 40 extending between the wheels38 and 39 is supported adjacent the length 33 of the conduit 32 and in aproximity that allows the pads or rollers 42 to contact and compressconduit 32 along the length 33, when the durable housing portion 22 isengaged with the disposable housing portion 20 and the belt 40 is drivenaround its annular path.

The durable housing portion 22 has a side or wall 44 (FIG. 3) that facesthe disposable housing portion 20, when the durable housing portion 22is engaged with the disposable housing portion 20 as shown in FIG. 2.The side or wall 44 defines a recess in which the wheels 38 and 39 arelocated. The recess in the side or wall 44 is open on the side facingthe disposable housing portion for the pads or rollers 42 of the belt 40to extend (and/or for a portion of the belt to extend, depending uponthe location of the wheels 38 and 39 relative to the open side of therecess) for engaging the length 33 of the conduit 32, when the durablehousing portion 22 is engaged with the disposable housing portion 20.The disposable housing portion 20 includes a side or wall 46 having anopening that faces the open side of the recess in the side or wall 44 ofthe durable housing portion 22, when the durable housing portion 22 isengaged with the disposable housing portion 20. The open side of therecess in the side or wall 44 is arranged to align with the open side orwall 46, to expose the length 33 of the conduit 32 and allow the pads orrollers 42 of the belt 40 to engage the length 33 of the conduit 32,when the durable housing portion 22 is engaged with the disposablehousing portion 20.

A drive device 47 is supported in the durable housing portion 22 and isoperatively connected to the drive wheel 38, to selectively rotate thedrive wheel 38 around its central axis. The drive device 47 maycomprise, for example, but not limited to a motor or other device forconverting electrical power into rotational motion. Various examples ofdrive devices are described below. The drive device 47 may beoperatively connected to the drive wheel 38, through any suitable gear,gear train, belt, shaft or other arrangement. Examples of suitablearrangements for operatively coupling an electronic motor to a rotatabledrive member are described in U.S. patent application Ser. No.11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method WithDisposable Portion,” which is incorporated herein by reference in itsentirety.

The drive device 47 is connected to a control circuit 48 supportedwithin the durable portion 22 of the delivery device, for controllingthe operation of the drive device according to a desired infusiondelivery program or profile. A delivery program or profile may be storedwithin a suitable electronic storage medium (not shown) located withinthe durable portion 22 and/or may be communicated to the delivery device12 from other sources, such as a CCD 16 or a computer 18 (as shown inFIG. 1). In such embodiments, the delivery program or profile may beemployed by the control circuit 48 to control the operation of the drivedevice 47 in accordance with the delivery program or profile.Alternatively or in addition, the control circuit 48 may control thedrive device 47 to deliver one or more discrete volumes of the infusionmedium in response to delivery demand control signals generated withinthe device 12 or communicated to the device 12 from other sources, suchas a CCD 16 or a computer 18 (as shown in FIG. 1). Examples of the typesof communications and/or control capabilities, as well as device featuresets and/or program options may be found in U.S. patent application Ser.No. 10/445,477 filed May 27, 2003, and entitled “External InfusionDevice with Remote Programming, Bolus Estimator and/or Vibration AlarmCapabilities,” and U.S. patent application Ser. No. 10/429,385 filed May5, 2003, and entitled “Handheld Personal Data Assistant (PDA) with aMedical Device and Method of Using the Same,” U.S. patent applicationSer. No. 09/813,660 filed Mar. 21, 2001, and entitled “Control Tabs ForInfusion Devices And Methods Of Using The Same,” all of which areincorporated herein by reference in their entirety.

The durable portion 22 may contain additional electronic circuitry (notshown) for communication with external devices such as the CCD 16 orcomputer 18, for storage of sensor data or other data, for processingand control functions, or for other functions. The durable portion 22may have a user interface (not shown) including one or more buttons,electronic display, or the like, and associated electronic interfacecircuitry to allow a user to access data and/or input data orinstructions to control electronic circuitry within the durable portion22.

The durable portion 22 may contain a battery, high energy capacitor orother electronic power source 50 for providing electrical power to thedrive device 47, control circuit 48 and other electronic circuitrycontained in the durable portion 22. In such embodiments, the battery,high energy capacitor or other electronic power source may berechargeable through a recharge connector (not shown) provided on thedurable portion 22. Alternatively, or in addition, the power source maybe removable and replaceable with respect to the durable housing portion22. In other embodiments, a battery, capacitor or other electronic powersource (not shown) may be supported on the disposable portion 20 andconnectable to the drive device 47, control circuit 48 and otherelectronic circuitry in the durable housing portion, through electricalconnectors (not shown in FIG. 4) that make an electrical connection uponthe durable portion 22 being coupled to the disposable portion 20,without additional manual manipulation. Such electrical connectors mayinclude one or more pairs of conductive pads, where each pair of pads isconnected to opposite poles of the power source and located on anysuitable surface of the disposable portion 20 that engages acorresponding surface on the durable portion 22, when the durableportion 22 is engaged with the disposable portion 20. In suchembodiments, the corresponding surface of the durable portion 22includes one or more corresponding pairs of conductive pads that areelectrically connected to the drive device 47, control circuit 48 andother electronic circuitry in the durable housing portion and arearranged to engage the conductive pads on the disposable portion, whenthe durable portion 22 is coupled to the disposable portion 20.

The durable portion 22 may include an interior volume 54 that containsthe drive device 47, control circuit 48, other electronic circuitrydescribed above, gears or other linkage to operatively couple the drivedevice 47 to the drive wheel 38 and, in some embodiments, a power source50. To protect those electrical and mechanical components from certainenvironmental conditions (such as, but not limited to, moisture, air,biological or medical fluids), the interior volume 54 of the durableportion 22 may be suitably sealed from the external environment by thehousing structure 55 that forms the durable portion 22. In theembodiment in FIGS. 4 and 5, the wheels 38 and 39 and belt 40 may besupported by the durable portion 22, in a recess located outside of theinterior volume 54. As shown in FIG. 5, a rotatable shaft 56 is axiallyconnected to the drive wheel 38. The shaft 56 may extend through anaperture in a wall of the housing structure 55. One or more seals 58,such as, but not limited to, an o-ring seal may be arranged around theaperture. Accordingly, the housing structure of the durable portion 22and the seal(s) 58 may form a suitable moisture-tight seal, air-tightseal and/or hermetic seal, to protect the electronic components locatedin the interior volume 54 and/or separate those components fromenvironmental, medical or biological materials to which the disposableportion 20 is exposed during normal operation.

A linkage structure for operably coupling the drive device 47 to theshaft 56, to transfer rotational motion to the shaft 56 may be includedin the sealed interior volume 54, to protect and/or separate thosemechanical components from environmental or biological materials, aswell. In FIG. 5, the linkage structure 60 comprises at least two engagedbevel gears or other suitable structure arranged to communicaterotational motion between a drive shaft 62 of the drive device 47 andthe shaft 56, where the axes of rotation of the shafts 62 and 56 arenon-parallel and may be orthogonal. Accordingly, as the drive device 47is controlled to selectively rotate the drive shaft 62, rotationalmotion of the drive shaft 62 is communicated through the linkagestructure 60 to provide rotational motion of the shaft 56 and, thus,rotational motion of the drive wheel 38 to selectively drive the belt 40around its annular path.

As the belt 40 is driven around its annular path, the pads or rollers 42engage and press against the length 33 of the conduit 32, when thedurable housing portion 22 is engaged with the disposable housingportion 20. As described above, the spacing between the first and secondwheels 38 and 39 provides a generally straight or flat portion of theannular path of the belt adjacent the length 33 of the conduit 32.Accordingly, as the belt 40 is selectively driven around its annularpath, the pads or rollers 42 on the belt engage and slide or roll alongthe length 33 of the conduit 32 for at least the distance between thefirst and second wheels 38 and 39. The reservoir 26 (or other structuralin or of the disposable housing portion) provides a generally flatsurface 27 for supporting the length 33 of the conduit 32 against thepressure applied by the pads or rollers 42 of the belt 40, to compressthe conduit 32 between each pad or roller 42 and the generally flatsurface, as the pad or roller 42 is moved along the length 33 of theconduit 32.

Another rotor 36 and reservoir 26 configuration that may be used in adelivery device of FIGS. 2-5 is shown in FIG. 6. The rotor 36 in FIG. 6has a plurality of pads or rollers 42 that are supported on a singlerotary wheel 70. In FIG. 6, the wheel 70 comprises a structure of spokesextending from a central hub, where each spoke has an end on which a pador roller 42 is disposed. The central hub of the wheel 70 may be coupledto a rotatable shaft similar to the rotatable shaft 56 that is coupledto the drive wheel 38 in FIG. 5. Accordingly, the wheel 70 may beselectively driven by the drive device 47 in a manner similar to themanner described above for driving the drive wheel 38 in FIG. 5.

The wheel 70 in FIG. 6 is supported for rotation about a central axis 72at a location on the durable housing portion 22 at which the pads orrollers 42 will engage the length 33 of the conduit 32, when the durablehousing portion 22 is engaged with the disposable housing portion 20. Inthe embodiment of FIG. 6, the length 33 of the conduit 32 is supportedon a concave-curved support surface 27 of the reservoir 26 (or otherstructure in or of the disposable housing portion 20). The concavecurvature and location of the support surface 27 in FIG. 6 may beselected to be about the same radius (or a slightly greater radius) asthe radial distance of the outer surface of the pads or rollers 42 fromthe axis 72 of the rotary wheel 70, when the durable housing portion 22is engaged with the disposable housing portion 20. As the rotary wheel70 is selectively driven by the drive device 47, the pads or rollers 42are moved around an annular, circumferential path and contact and slideor roll along the curved length 33 of the conduit 32. The pads orrollers compress the conduit 32 during their motion along the curvedlength 33, to provide a peristaltic pumping action (a pressuredifferential in the conduit 32 across the rotor 36) sufficient to drawinfusion fluid from the reservoir 26, through the conduit 32 and to theinjection site 35. The curvature of the support surface 27 in FIG. 6 canhelp maximize the length 33 of the engageable portion of the conduit 32,to improve the peristaltic pumping action. The rotor 36 configuration ofFIG. 6, thus, does not require multiple wheels and does not require abelt structure as described with respect to FIG. 4. In yet furtherembodiments, the rotor 36 of FIG. 4 or 6 may be supported on thedisposable housing portion 20 and connectable to a rotary drive devicesupported on the durable housing portion 22. Suitable structure forconnecting a rotary drive device in one housing portion to a rotor inanother housing portion is disclosed in U.S. patent application Ser. No.11/211,095, filed Aug. 23, 2005, titled “Infusion Device And Method WithDisposable Portion,” which is incorporated herein by reference in itsentirety.

Another peristaltic drive configuration in a delivery device 112 isshown in FIGS. 7-12. The embodiment in FIGS. 7-12 may employ a two-parthousing structure, as described above, including a disposable housingportion 120 and a durable housing portion 122 that may function toengage and disengage similarly to the disposable and durable housingportions 20 and 22 described above. The two housing portions 120 and 122are shown in an engaged orientation, in FIG. 7. The durable housingportion 122 is shown in a top-down view in FIG. 8 and in a side view inFIG. 9. The disposable portion 120 is shown in a bottom-up view in FIG.10 and a side view in FIG. 11. Another side view of the two housingportions 120 and 122 is shown in FIG. 12, with the disposable housingportion 120 oriented to be engaged with the durable housing portion 122,but located above and separated from the durable housing portion 122.

The disposable housing portion 120 supports a reservoir 126 having aninterior volume for containing a fluidic infusion medium. The reservoir126 may be similar in structure and function to the reservoir 26described above.

The reservoir 126 has an outlet port 130, through which the infusionmedium contained within the interior of the reservoir 126 may becommunicated out of the reservoir. The outlet port 130 is open to theinterior volume of the reservoir 126 and may include suitabletube-connection structure. A tube-shaped conduit 132 having an internalfluid flow path is connected, at a first end, in fluid-flowcommunication with the outlet port 130. The conduit 132 may be made ofany suitable material, including, but not limited to silicone or otherplastic, metal, ceramic or composite material. At least a portion 133 ofthe length of the conduit 132 is made of a resilient, flexible material,such as, but not limited to a silicone or other plastic materialsuitable for repeated contact with pads or rollers of a peristalticrotor, as described below, to repeatedly compress and return the fluidflow path within the length portion 133 of the conduit 132. In someembodiments, the entire length of the conduit 132 is made of theresilient, flexible material.

A second end of the conduit 132 is connected in fluid flow communicationwith an injection site 135 located on the disposable housing portion120. The injection site 135 may be similar to the injection site 35described above. For example, the injection site 135 may include aneedle inserter device for inserting a hollow needle or cannula into apatient-user's skin, when the delivery device 112 is secured to apatient-user's skin. Examples of needle inserter devices that may beused for moving a hollow needle or cannula into a patient-user andconnecting the hollow needle or cannula in fluid flow communication witha reservoir are described in U.S. patent application Ser. No.11/211,095, filed Aug. 23, 2005, and U.S. Patent Application No.60/839,840, titled “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device Method”, filed Aug. 23,2006, (attorney docket no. 047711-0384), each of which is incorporatedherein by reference. Other needle/cannula insertion tools may be used(or modified for use) to insert a needle and/or cannula, such as forexample U.S. patent application Ser. No. 10/389,132 filed Mar. 14, 2003,and entitled “Auto Insertion Device For Silhouette Or Similar Products,”and/or U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002,and entitled “Insertion Device For Insertion Set and Method of Using theSame,” both of which are incorporated herein by reference in theirentirety. In further embodiments, other suitable needle or cannulainserter devices may be employed. In yet further embodiments, a set ofmicro-needles may be employed, instead f a hollow needle or cannula.

In the embodiment shown in FIGS. 8-12, the length portion 133 of theconduit 132 is supported on a surface 127 of the disposable housingportion 120, at a location arranged to be contacted and compressed byone or more pads or rollers of a peristaltic rotor, when the durablehousing portion 122 is engaged with the disposable housing portion 120.The length portion 133 may extend in a circular path around at least aportion of the circumference of a circle (as shown in FIG. 10) having aradius about the same as the radius at which one or more wheels or padsof a rotor of a peristaltic pumping arrangement (described below) arelocated. As shown in FIG. 11, the conduit support surface 127 may belocated within a recessed portion, such as an annular groove, providedon a side of the disposable housing portion 120 that faces and engagesan opposite-facing side of the durable housing portion 122, when thedisposable housing portion 120 and the durable housing portion 122 areengaged in the manner shown in FIG. 7. In such embodiments, the annulargroove may have a radius and width sufficient to receive one or morewheels or pads of a rotor of a peristaltic pumping arrangement(described below). The location of the conduit 132 in an annular groovemay help to avoid damage to the conduit during use, storage or shipping.

The durable housing portion supports a rotor 136 of a peristalticpumping arrangement. The rotor 136 comprises a rotor wheel 137 thatsupports at least one roller or pad 142, and preferably, a plurality ofrollers or pads 142 located at spaced intervals around the perimeter ofthe rotor wheel 137. The rollers or pads 142 may comprise rotatablewheels, projections, nubs or the like. In embodiments in which therollers or pads 142 are rotatable wheels, each wheel is supported forrotation on a respective spoke of the rotor wheel 137, where the axis ofrotation of each wheel is orthogonal to (and may be perpendicular to)the axis of rotation of the rotor wheel 137. That arrangement allows therollers or pads 142 to readily align with and operatively engage theflexible portion 133 of the conduit 132, when the durable housingportion 122 is engaged with the disposable housing portion 120. In theembodiment of FIG. 8, the rotor 136 includes three rollers or pads 142.In other embodiments, any suitable number rollers or pads 142 may beemployed. The rollers or pads 142 are located at a radial distance fromthe axis 147 of the rotor 136 that is about the same as the radius ofthe circle circumscribed by the flexible portion 133 of the conduit 132and the radius of the annular groove for the support surface 127 on thedisposable housing portion 120.

The rotor 136 is operatively coupled to a drive device 146, forselective rotation about the rotor axis 147 by the drive device 146. Thedrive device 146 is connected to a control circuit 148 supported withinthe durable portion 122 of the delivery device, for controlling theoperation of the drive device according to a desired infusion deliveryprogram or profile. A delivery program or profile may be stored within asuitable electronic storage medium (not shown) located within thedurable portion 122 and/or may be communicated to the delivery device 12from other sources, such as a CCD 16 or a computer 18 (as shown in FIG.1). In such embodiments, the delivery program or profile may be employedby the control circuit 148 to control the operation of the drive device146 in accordance with the delivery program or profile. Alternatively orin addition, the control circuit 148 may control the drive device 146 todeliver one or more discrete volumes of the infusion medium in responseto delivery demand control signals generated within the device 12 orcommunicated to the device 12 from other sources, such as a CCD 16 or acomputer 18 (as shown in FIG. 1). Examples of the types ofcommunications and/or control capabilities, as well as device featuresets and/or program options may be found in U.S. patent application Ser.No. 10/445,477 filed May 27, 2003, and entitled “External InfusionDevice with Remote Programming, Bolus Estimator and/or Vibration AlarmCapabilities,” and U.S. patent application Ser. No. 10/429,385 filed May5, 2003, and entitled “Handheld Personal Data Assistant (PDA) with aMedical Device and Method of Using the Same,” U.S. patent applicationSer. No. 09/813,660 filed Mar. 21, 2001, and entitled “Control Tabs ForInfusion Devices And Methods Of Using The Same,” all of which areincorporated herein by reference in their entirety.

The durable portion 122 may contain additional electronic circuitry (notshown) for communication with external devices such as the CCD 16 orcomputer 18, for storage of sensor data or other data, for processingand control functions, or for other functions as described above withrespect to the circuitry in durable housing portion 22. The durableportion 122 may have a user interface (not shown) including one or morebuttons, electronic display, or the like, and electronic interfacecircuitry to allow a user to access data and/or input data orinstructions to control electronic circuitry within the durable portion122.

The durable portion 122 may contain a battery, high energy capacitor orother electronic power source 150 for providing electrical power to thedrive device 146, control circuit 148 and other electronic circuitrycontained in the durable portion 122. In such embodiments, the battery,high energy capacitor or other electronic power source may berechargeable through a recharge connector (not shown) provided on thedurable portion 122. Alternatively, or in addition, the power source maybe removable and replaceable with respect to the durable housing portion122.

In other embodiments, such as shown in FIG. 13, a battery, capacitor orother electronic power source 150′ may be supported on the disposableportion 120′. More specifically, in the embodiment of FIG. 13, adisposable housing portion 120′ and a durable housing portion 122′function in a manner similar to the disposable housing portion 120 anddurable housing portion 122 described above. However, in FIG. 13, thepower source 150′ is electrically connectable, through connectors 151′and 152′, to a drive device 146′, a control circuit 148′ and otherelectronic circuitry in the durable housing portion 122′ (similar to thedrive device 146, control circuit 148 and other electronic circuitry inthe durable housing portion 122 described above). The electricalconnectors 151′ and 152′ may comprise any suitable structure that makesan electrical connection upon the durable portion 122′ being coupled tothe disposable portion 120′, without additional manual manipulation.However, further embodiments may be configured in which additionalmanual manipulation of the disposable housing portion 120′, the durablehousing portion 122′ and/or a manual operator (such as, but not limitedto a button, lever or the like) may be required to provide theelectrical connection, once the disposable housing portion 120′ and thedurable housing portion 233′ are engaged.

In the embodiment shown in FIG. 13, the electrical connector 151′comprises a pair of electrical leads extending from the positive andnegative poles of the power source 150′, with a conductive pad on anexposed end of each lead. The electrical connector 152′ comprises a pairof electrical conductors connected to one or more of the control circuit148′, the drive device 146′ and other electronic circuitry in thedurable housing portion 122′. The embodiment of FIG. 13 includes areservoir 126′, conduit 132′ and a rotor 136′ (similar to the reservoir126, conduit 132 and rotor 136 described above).

In the embodiments of FIGS. 8-13, the durable portion 122, 122′ mayinclude an interior volume 154, 154′ that contains the drive device 146,146′ control circuit 148, 148′ and other electronic circuitry asdescribed above. In addition, the interior volume 154, 154′ may containgears or other linkage structure 160, 160′ (similar to the linkagestructure 60 described above) to operatively couple the drive device146, 146′ to a rotatable rotor shaft 156, 156′. To protect thoseelectrical and mechanical components from certain environmentalconditions (such as, but not limited to, moisture, air, biological ormedical fluids), the interior volume 154, 154′ of the durable portion122, 122′ may be suitably sealed from the external environment by thehousing structure 155, 155′ that forms the durable portion 122, 122′.

In the embodiments in FIGS. 8-13, the rotor 136, 136′ may be supportedby the durable portion 122, 122′, outside of the interior volume 154,154′. The rotatable shaft 156, 156′ is axially connected to the rotor136, 136′. The shaft 156, 156′ may extend through an aperture in a wallof the housing structure 155, 155′. One or more seals 158, 158′, suchas, but not limited to, an o-ring seal may be arranged around theaperture. Accordingly, the housing structure of the durable portion 122,122′ and the seal(s) 158, 158′ may form a suitable moisture-tight seal,air-tight seal and/or hermetic seal, to protect the electroniccomponents located in the interior volume 154, 154′ and/or separatethose components from environmental, medical or biological materials towhich the disposable portion 120, 120′ is exposed during normaloperation.

Accordingly, as the drive device 146, 146′ is controlled to selectivelyrotate the drive shaft 162, 162′, rotational motion of the drive shaft162, 162′ is communicated through the linkage structure 160, 160′ toprovide rotational motion of the shaft 156, 156′ and, thus, rotationalmotion of the rotor 136, 136′ to selectively drive the rollers or padson the rotor through an annular path.

As the rollers or pads on the rotor 136, 136′ are driven in theirannular path, the rollers or pads engage and compress the conduit 132,132′ during their motion along the annular path to provide a peristalticpumping action (a pressure differential in the conduit 132, 132′ acrossthe rotor 136, 136′) sufficient to draw infusion fluid from thereservoir 126, 126′, through the conduit 132, 132′ and to the injectionsite 135, 135′.

In the embodiments of FIGS. 4-13, a compression structure comprising atleast one roller or pad of a rotor 136, 136′ is arranged to engage andcompress a portion of the conduit 132, 132′ that extends from theinfusion medium reservoir 126, 126′. According to a further embodiment,a compression structure, such as at least one roller or pad, is arrangedto compress the infusion medium reservoir, itself For example, anembodiment of a delivery device 212 as shown in FIG. 14 includes adisposable housing portion 220 and a durable housing portion 222,similar in structure and function to the disposable and durable housingportions 20 and 22, respectively, discussed above. The disposablehousing portion 220 and the durable housing portion 222 are configuredto be engaged, as shown in FIG. 14, for operation, yet be separable (asdescribed above with respect to the disposable and durable housingportions 20 and 22).

The disposable housing portion 220 has an interior volume 224 thatcontains a reservoir 226. The reservoir 226 is arranged to abut againsta rigid surface 227 within the disposable housing portion 220. In theembodiment shown in FIG. 14, the reservoir 226 abuts against the innersurface 227 of the outer wall of the structure that forms the disposablehousing portion 220. Also in the embodiment shown in FIG. 14, the innersurface 227 is curved, corresponding to the curvature of the outer wallof the structure that forms the disposable housing portion 220. In otherembodiments, the rigid surface 227 against which the reservoir 226 abutsmay be a surface of another wall (not shown) of the disposable housingportion 220 or the surface of another structure (not shown) locatedwithin the interior volume 224 of the disposable housing portion 220.

The reservoir 226 may comprise a flexible bag-like container, atube-like structure or other container structure having at least oneflexible wall for receiving compression pressure from a track roller, asdescribed below. The reservoir 226 includes an interior volume forcontaining an infusion medium. In one example embodiment, the reservoir226 comprises a flexible bag-like container made of a flexible plastic,metal or composite material, suitably compatible with the infusionmedium. A conduit having an internal fluid flow path is coupled in fluidflow communication with the interior of the reservoir 226 and aninjection site 235, for providing a fluid flow path from the reservoirto the injection site. The injection site 235 may be similar to theinjection site 35 or 135 described above.

The housing structure of the disposable housing portion 220 has a wall228 that faces an opposite-facing wall 229 of the durable housingportion 222, when the disposable housing portion 220 and the durablehousing portion 222 are engaged as shown in FIG. 14. The wall 228 of thedisposable housing portion 220 is provided with an opening that alignswith a corresponding opening of the wall 229 of the durable housingportion, when the disposable housing portion 220 and the durable housingportion 222 are engaged as shown in FIG. 14.

The durable housing portion has an interior volume 230 that contains amovable track 232 (such as a rack of a rack and pinion arrangement), adrive device 246, drive control electronics 248, other electronics (notshown), a power source 250 and linkage gears or other linkage structure260 for operatively coupling the drive device 246 to the track 232, tomove the track 232 along an arched path. The drive device 246 maycomprise a drive device as described above with respect to drive device47. Similarly, the drive control electronics 248, other electronics (notshown) and power source 250 may comprise drive electronics 48, otherelectronics and a power source 50 as described above with respect to theembodiment of FIGS. 2-5.

In the embodiment of FIG. 14, the track 232 is curved to correspond(approximate) the curvature of the inner surface 227 in the disposablehousing portion 220. The track 232 is supported to move in an archedpath 252 that extends along the direction of curvature of the track 232.The track 232 has a surface provided with serrations or teeth configuredfor engaging corresponding serrations or teeth on an engagement gear 262(such as a pinion gear of a rack and pinion arrangement) of the linkage260. The engagement gear 262 is operatively coupled through the rest ofthe linkage 260 to be selectively, rotatably driven by the drive device246, for example, but not limited to the linkage 60 that operativelycouples the drive device 47 to selectively, rotatably drive the wheel 38described above. In the embodiment of FIG. 14, the track 232 is providedwith serrations or teeth the curved surface of the track that forms aconcave shape. However, in other embodiments, the track 232 may beprovided with serrations or teeth along its convex curved side or on thesurface facing out of the page or the surface facing into the page(relative to the orientation shown in FIG. 14), for engaging anengagement gear 262 suitably located adjacent the serrated or toothedsurface of the track 232.

The track 232 is configured to extend through the aperture in the wall229 of the durable housing portion 222, such that a portion of thecurved length of the track 232 is located inside of the internal volumeof the durable housing portion 222 and a further portion of the curvedlength of the track 232 extends out of the aperture in the wall 229.When the disposable housing portion 220 and the durable housing portion222 are engaged, as shown in FIG. 14, the portion of the track 232 thatextends out of the aperture in the wall 229 of the durable housingportion 222 is arranged to extend into the aperture in the wall 228 ofthe disposable housing portion 220.

The track 232 may be supported for movement along the arcuate path 252by a combination of the engagement gear 262 and one or more of a furthergear (not shown) engaging the convex side of the curved track 232 or oneor more support rollers or pads 264 connected to the track 232 andarranged to slide or roll along a curved surface such as the interiorsurface of the structure that forms the outer wall of the durablehousing portion 222. Alternatively, or in addition, such support rollersor pads 264 may be arranged to roll along another curved surface of orwithin the durable housing portion 222. Alternatively, or in addition,the track 232 may be guided within one or more grooves, channels orother guide structures (not shown) formed on one or both of the durablehousing portion 222 and disposable housing portion 220, for engaging thetrack 232 and maintaining the track 232 along the arcuate path 252.

A compression mechanism comprising at least one compression pad orroller 266 is supported on the portion of the track 232 that extendsinto the interior of the disposable housing portion, when the disposablehousing portion 220 and the durable housing portion 222 are engaged asshown in FIG. 14. The compression pad(s) or roller(s) 266 may bearranged to impart a compression force on a flexible wall of thereservoir 226, when the disposable housing portion 220 and the durablehousing portion 222 are engaged as shown in FIG. 14.

In particular, the compression pad(s) or roller(s) 266 may engage aflexible wall of the reservoir 226 and impart a compression forcedirected toward the surface 227 against which the reservoir 226 isabutted. The compression force imparted by the compression pad(s) orroller(s) 266 is sufficient to compress the portion of the reservoir 226that is located between the compression pad(s) or roller(s) 266 and thesurface 227. The width dimension (in the direction into and out of thepage in the orientation shown in FIG. 14) of the compression pad(s) orroller(s) 266 is at least as great as the width dimension (in thedirection into and out of the page in the orientation shown in FIG. 14)of the reservoir 226. The compression pad(s) or roller(s) 266 arearranged to slide or roll along the reservoir 266 and compress thereservoir, as the track 232 is moved in the arcuate path 252, in thedirection of arrow 272. Accordingly, as the compression pad(s) orroller(s) 266 compress a portion 270 of the reservoir 226, as shown inFIG. 14, the internal volume of an infusion-medium-containing portion271 of the reservoir 226 reduces and the pressure within theinfusion-medium-containing portion of the reservoir 226 increases tocause infusion medium to be forced out of the reservoir 226, toward theinjection site 235.

While the compression pad(s) or roller(s) 266 in FIG. 14 are coupled tothe moveable track 232, in other embodiments, one or more compressionpad(s) or rotatable roller(s) may be supported in a fixed relation (withroller axis in a fixed location) relative to the disposable housingportion 220, while the reservoir may be coupled to the moveable track.For example, FIG. 15 shows an embodiment in which a pair of compressionpads or rollers 266′ are arranged adjacent each other and secured to thedisposable housing portion 220 in a fixed location (although they may berotatable) with respect to the disposable housing portion 220. The widthdimension (in the direction into and out of the page in the orientationshown in FIG. 15) of the compression pads or rollers 266′ is at least asgreat as the width dimension (in the direction into and out of the pagein the orientation shown in FIG. 15) of the reservoir 226′.

The embodiment of FIG. 15 includes a reservoir 226′ and a moveable track232′, which may be similar to the reservoir 226 and track 232 describedabove with respect to FIG. 14. However, in FIG. 15, the reservoir 226′is secured to the portion of the track 232′ that extends into thedisposable housing portion, when the disposable housing portion 220′ andthe durable housing portion 222′ are engaged (in a manner similar tothat shown in FIG. 14). Also, in the embodiment of FIG. 15, the drivedevice and linkage (246 and 260 in FIG. 14) are configured toselectively move the track 232′ in the direction of arrow 272′ (oppositeto the direction of arrow 272 in FIG. 14), to selectively pull a portionof the reservoir 226′ through a space between the compression pads orrollers 266′.

The spacing between the compression pads or rollers 266′ is selected toallow the compression pads or rollers 266′ to compress the portion ofthe reservoir 226′ located between the pads or rollers, to substantiallydeplete infusion medium from that portion of the reservoir and reducethe infusion-medium-containing portion of the reservoir 226′, as thereservoir is pulled through the space between the compression pads orrollers 266′ by movement of the track 232′ in the direction of arrow272′. Accordingly, as the reservoir 226′ is compressed by thecompression pad(s) or roller(s) 266′, the internal volume of aninfusion-medium-containing portion 271′ of the reservoir 226′ reducesand the pressure within the infusion-medium-containing portion of thereservoir 226′ increases to cause infusion medium to be forced out ofthe reservoir 226′, toward the injection site 235′. The reservoir 226′and moveable track 232′ of FIG. 15 may be used in place of the reservoir226 and moveable track 232 of FIG. 14.

In further embodiments, a reservoir 226′ may extend between (and becompressed by) a pair of compression rollers or pads 266′ similar to thearrangement shown in FIG. 15. However, in further embodiments, thecompression pads or rollers 266′ comprise at least one (and, preferably,two) rotatable roller members, and where one or both of the rollermembers is (are) operatively coupled to a drive device for rotation ofthe roller member(s). By rotatably driving the roller member(s) 266′with a drive device, the depleted portion 271′ of the reservoir 226′ maybe driven through the space between the roller member(s) 266′, tofurther reduce the internal volume of an infusion-medium-containingportion 271′ of the reservoir 226′ and, thus, increase the pressurewithin the infusion-medium-containing portion of the reservoir 226′ tocause infusion medium to be forced out of the reservoir 226′, toward theinjection site 235′. Also, while embodiments shown in FIGS. 14 and 15employ a track 232 having a curved shape, to accommodate the circularshape of the interior of the disposable housing portion 220 and minimizespace usage, other embodiments may employ a track 232 having a generallystraight length along its serrated or toothed side.

A further embodiment of a delivery device 212″ in FIGS. 16 and 17 issimilar in various structural and functional features as the deliverydevice 212 described above, in that the delivery device 212″ includes adisposable housing portion 220″ and a durable housing portion 222″(similar to the disposable housing portion 220 or 220′ and durablehousing portion 222 or 222′ described above). In FIGS. 16 and 17, atrack 232″ (similar to the track 232 or 232′ discussed above) operateswith a plunger head 280 attached to or engaged with the end of the trackportion that extends into the disposable housing portion 220″. The track232″ may be operatively coupled to a drive device 246″, through suitablelinkage structure 260″, as described above with respect to the track232, drive device 246 and linkage structure 260 in FIG. 14.

A reservoir 226″ is located in the disposable housing portion 220″ andhas an interior volume for containing an infusion medium. The reservoir226″ may comprise a rigid, tubular structure or channel having a curvedinterior volume, where the curved interior volume extends along a curvedlongitudinal direction and has a radius of curvature about the same asthe radius of curvature of the track 232″. The interior volume of thereservoir 226″ may be connected to an injection site 235″. For example,the reservoir 226″ may comprise structure and functionality similar tothe reservoirs described in co-pending U.S. Patent Application Ser. No.60/839,822, filed Aug. 23, 2006, titled “Infusion Medium Delivery DeviceAnd Method For Driving Plunger In Reservoir” (attorney docket no.047711-0382), but having a curved interior volume. In one embodiment, aplunger head 280 may be disposed within the reservoir, such that one endof the track 232″ is arranged to abut (engage) the plunger head 280,when the durable housing portion 222″ is engaged with the disposablehousing portion 220″, as shown in FIG. 16, yet separate (disengage) fromthe plunger head 280 when the durable housing portion 222″ is separatedfrom the disposable housing portion 220″. In another embodiment, theplunger head 280 may be fixed to one end of the track 232″ and may beinserted into the reservoir 226″, when the durable housing portion 222″is engaged with the disposable housing portion 220″, as shown in FIG.16, and may be withdrawn from the reservoir 226″ when the durablehousing portion 222″ is separated from the disposable housing portion220″.

In the embodiment shown in FIG. 16, the reservoir 226″ comprises acurved tubular structure having a curved central axis 282 extending inthe longitudinal direction of the tubular structure. The curved tubularstructure of the reservoir 226″ in FIG. 16 has an outer radius ofcurvature approximately equal to the radius of curvature of the innerwall surface 227″ of the disposable housing portion 220″. The curvatureof the reservoir 226″, thus, may be selected to help maximize theefficient use of the interior volume 224″ of the disposable housingportion 220″, by minimizing unused, open space within the interiorvolume 224″ without reducing the interior volume of the reservoir.Accordingly, a curved reservoir may be employed to help minimize certaindimensions of the delivery device 12″, without reducing the reservoircapacity.

The plunger head 280 in FIGS. 16 and 17 has a suitable shape anddimension to be moveable within the interior volume of the reservoir226″. The plunger head 280 may include one or more seals 284, such as,but not limited to o-ring seals, to provide a fluid seal between theouter peripheral surface of the plunger head and the inner surface ofthe reservoir 226″. When engaged with the end of the track 232″, theplunger head 280 is moveable in the direction of arrow 286, upon thetrack 232″ being driven by the drive device 246″ in the direction ofarrow 286. As the plunger head 280 is moved within the reservoir 226″ inthe direction of arrow 284, the infusion-medium-containing volume of thereservoir 226″ is reduced and the pressure within theinfusion-medium-containing portion of the reservoir 226″ iscorrespondingly increased, to cause infusion medium to be forced out ofthe reservoir 226″, toward the injection site 235″.

A delivery device 312 according to a further embodiment of the presentinvention includes a reservoir having a generally disk-like shape with acircular or elliptical cross-section, or other smooth cross-sectionalshape, to accommodate sealing between a reservoir plunger and the innersurface of the reservoir. In the embodiment of FIG. 18, a disposablehousing portion 320 comprises a reservoir 326 that has an enclosedinterior volume with a generally circular cross-sectional shape (forminga partial circle), such that the inner wall surface of the reservoir hasa radius of curvature that forms at least a partial circle. Thedisposable housing portion 320 may be formed of any suitable material,such as described above with respect to the disposable housing portion20.

In FIG. 18, the inner wall surface 327 of the reservoir 326 is (or hasthe same shape and similar dimension as) the outer peripheral wall ofthe reservoir 326. Accordingly, the volume of the reservoir 326 may bemaximized for a given outer dimension of the disposable housing portion320.

A plunger in the form of a rotor arm 336 is supported for rotationwithin the reservoir 326. In FIG. 18, the rotor arm 336 is supported atone end on a rotation axis 338, about which the arm 336 may rotate inthe direction of arrow 340. The rotor arm 336 has a width dimension(extending into and out of the page, in the orientation shown in FIG.18) about as great as the width dimension (into and out of the page, inthe orientation shown in FIG. 18) of the reservoir 326, such that therotor arm spans the full width (into and out of the page, in theorientation shown in FIG. 18) of the reservoir 326. The rotor arm 336may be made of any suitably rigid material, including, but not limitedto a metal, plastic, ceramic or composite material, or combinationsthereof.

In the embodiment of FIG. 18, the rotor arm axis 338 is coaxial with theaxis of the circular shape of the inner wall surface of the reservoir(which may be the same surface as, or coaxial with, the inner wallsurface 327 of the disposable housing portion 320). The arm 336 extendsfrom the rotation axis 338, radially outward a distance about equal to(or slightly less than) the radius of the inner wall surface of thereservoir 326, toward the inner wall surface of the reservoir. One ormore seals 342 may be secured to the second end of the arm 336, toprovide a fluid seal between the inner wall surface of the reservoir andthe arm 336. One or more seals (not shown) may be provided on thesurfaces of the arm 336 facing into and out of the page in theorientation shown in FIG. 18, to provide a fluid seal between the arm336 and the bottom and top surfaces of the reservoir 326 (with respectto the orientation shown in FIG. 18). One or more air passages 343 maybe provided between the interior of the reservoir 326 and an externalenvironment, to equalize pressure within the reservoir 326, as theinfusion medium is driven out of the reservoir or filled or re-filledinto the reservoir. The air passages may be covered with anair-permeable material that inhibits the passage of infusion media, butallows the passage of air. Examples of structures that permit air-flow,but that inhibit fluids can be found in U.S. patent application Ser. No.10/328,393 filed Dec. 22, 2003, and entitled “Reservoir Connector,” andU.S. patent application Ser. No. 10/699,429 filed Oct. 31, 2003, andentitled “External Infusion Device with a Vented Housing,” both of whichare incorporated herein by reference in their entirety.

An outlet 341 is provided in fluid flow communication with the interiorvolume of the reservoir 326 and couples to a conduit 339 that is influid flow communication with an injection site 335. The injection site335 may be similar to the injection site 35, 135 and 235 describedabove. As the arm 336 is selectively driven in the direction of arrow340, the pressure of the infusion medium within the interior of thereservoir 326 increases and the infusion medium is forced out of theoutlet 341 and through the conduit 339 to the injection site 335. In theembodiment shown in FIG. 18, the conduit 339 extends out from thedisposable housing portion, to an injection site 335 that is external tothe disposable housing portion. In further embodiments, the injectionsite 335 may be located within the disposable housing portion, forexample, as shown in broken lines at 335′ in FIG. 18.

A durable housing portion 322 shown in FIG. 19 is configured to engageand operatively couple to the disposable housing portion 320 in FIG. 18.The durable housing portion 322 may include an enclosed interior volumethat contains a drive device, drive control electronics, otherelectronics, a power source and linkage structure, as described abovewith respect to the durable housing portion 22 of FIG. 4.

In the embodiment of FIG. 19, the drive device within the durablehousing portion is operatively coupled, through suitable linkagestructure as described above, to rotatably drive a rotatable shaft 344.The rotatable shaft 344 is supported for rotation by the durable housingportion 322 and extends through an aperture in a wall of the durablehousing portion 322. One or more seals, such as, but not limited too-ring seals, may be disposed around the aperture in the durable housingportion wall through which the shaft 344 extends.

The end of the shaft 344 that extends outside of the durable housingportion 322 may include a mating connector, for engaging and operativelymating with a corresponding mating connector coupled to the rotor arm336. For example, the shaft 344 may have a non-circular cross-section(cross-section in the plane perpendicular to the longitudinal axis ofthe shaft 344) that mates with an axial-directed aperture 335 in the arm336. The aperture 335 has a non-circular cross-section shape thatcorresponds to the cross-section shape of the shaft 344 to allow theshaft 344 to be inserted into the aperture 335 and to rotate the arm 336with rotation of the shaft 344. In the embodiment of FIGS. 18 and 19,the non-circular cross-sectional shape of the shaft 344 and the aperture335 is generally a “D” shape. However, other embodiments may employother suitable, non-circular shapes, including, but not limited to,oval, elliptical, polygonal, star, cross shapes or the like.

Accordingly, in the embodiment of FIGS. 18 and 19, the drive devicewithin the durable housing portion is operatively coupled, throughsuitable linkage structure, to rotatably drive a rotatable shaft 344.FIG. 20 shows another embodiment in which a similar drive device withina similar durable housing portion may be operatively coupled, throughsuitable linkage structure, to rotatably drive a rotary shaft toselectively drive fluid from a reservoir.

The structure in FIG. 20 includes a rotor 502 supported for rotationrelative to a housing 504, about an axis A₅. The housing 504 may belocated within the disposable housing portion 20 and/or may be a sectionof the disposable housing portion 20 described above with respect toFIGS. 2 and 3. The housing 504 may be selectively engaged with anddisengaged from a durable housing portion that contains a drive device,as described above with respect to the drive device 47.

In the embodiment of FIG. 20, the housing 504 has a base portion 504 aand a cover portion 504 b. The base portion 504 a and cover portion 504b may be separate elements that are connected together or may be formedas a unitary structure. In embodiments in which the base portion 504 aand cover portion 504 b are separate elements that are connectedtogether, one or more seals, such as, but not limited to, o-ring orannular, flat gasket seals, may be provided between the base portion 504a and the cover portion 504 b, to inhibit leakage of fluid (such as aninfusion medium) between those elements, when they are connectedtogether.

First and second channels 506 and 508 extend through the base portion504 a of the housing 504, in a spaced relation relative to each otherand to the axis A₅ of the rotor 502. In the embodiment of FIG. 20, thechannels 506 and 508 are located at 180 degrees around the axis A₅,relative to each other. However, in other embodiments, the channels maybe located at other suitable spacing around the axis A₅, relative toeach other.

The first and second channels 506 and 508 in the base portion 504 a ofthe housing 504 form fluid inlet and outlet channels, respectively, asdescribed below. The cover portion 504 b of the housing 504 has aninterior volume and a cam surface 528 that includes a cam lobe 528 b forcontacting cams, a non-camming surface portion 528 a that does not movethe cams and a ramp portion 528 c connecting the non-camming surfacewith the cam lobe. One end of each of the first and second channels 506and 508 is open to the interior volume of the housing 504.

The rotor includes a shaft 510 that extends through a channel 512 in thebase portion 504 a and through an opening 514 in the cover portion 504 bof the housing 504. The rotor shaft 510 has one end segment 510 a thatextends through the opening 514 and out of the housing 504 and isarranged for operable connection with a drive device, either directly orthrough suitable linkage structure, for example, as described above withrespect to the connection of the rotary shaft 344 with the drive devicearm 336, when the disposable housing portion 20 and the durable housingportion 22 are engaged. For example, the rotor shaft 510 may include anon-circular cross-sectional shape that mates with a correspondinglyshaped aperture in an end of a rotatable shaft that is operativelyconnected to the drive device (similar to the non-circular,cross-section shaped mating elements of the shaft 344 and aperture 335in FIGS. 18 and 19. In FIG. 20, The rotor shaft has a second end segment510 b that extends through the channel 512 in the base portion 504 a andout of the housing 504. The rotor also includes a disk-shaped body 510c, located between the two end segments 510 a and 510 b. The endsegments 510 a and 510 b and the disk-shaped body 510 c of the rotor 510may be formed as multiple separate elements connected together, or maybe formed as a single, unitary structure in the configuration shown inFIG. 20.

The rotor body 510 c is located within the interior volume of the coverportion 504 a of the housing 504. The rotor body 510 includes at leasttwo cam-follower channels 516 and 518, located in a spaced relationrelative to each other and to the axis As of the rotor 502,corresponding to the spaced relation of the first and second channels506 and 508 in the base portion 504 a of the housing 504. Thecorresponding spaced relation allows the two cam-follower channels 516and 518 in the rotor body 510 c of the rotor 510 to simultaneously alignwith the first and second channels 506 and 508 in the base portion 504 aof the housing 504. In the embodiment of FIG. 20, the cam followerchannels 516 and 518 are located at 180 degrees around the axis A₅,relative to each other. However, in other embodiments, the cam followerchannels 516 and 518 may be located at other suitable spacing around theaxis A₅, relative to each other. Also, while the embodiment in FIGS.20-23 includes two cam follower channels and two associated camfollowers, other embodiments may include no more than one cam followerchannel and associated cam follower or more than two cam followerchannels and associated cam followers.

A cam follower 520 is located in the cam follower channel 516 and asecond cam follower 522 is located in the cam follower channel 518. Thecam followers 520 and 522 are moveable within their respective camfollower channels 516 and 518, in the directions of arrows 524 and 525.In the illustrated embodiment, the cam follower channels 516 and 518 andthe cam followers 520 and 522 are arranged such that the directions ofmovement 524 and 525 of the cam followers 520 and 522 are substantiallyparallel to the axis A₅ of the rotor 510. However, in other embodiments,the channels 516 and 518 and cam followers 520 and 522 may be arrangedfor movement in a direction transverse to the axis As of the rotor 510.

The cam followers 520 and 522 may be made of any suitably rigidmaterial, including, but not limited to, metal, plastic, ceramic,composite material or the like. The cam followers 520 and 522 have ashape that allows them to fit within the respective cam followerchannels 516 and 518 and move in the directions of arrows 524 and 525,relative to the body 510 c of the rotor 510. Each cam follower 520 and522 includes a head portion 520 a and 522 a, respectively, on one endthat is external to rotor body 510 c. The head portions 520 a and 522 ahave a size or shape that inhibits the head portions from passingthrough the respective cam follower channel 516 or 518. The camfollowers 520 and 522 each have a length in the axial dimension A₅sufficient to allow an end portion of each cam follower 520 and 522opposite to the head portions 520 a and 522 a, to extend a distance outof the channels 516 and 518, when the respective cam follower 520 and522 is moved to its full extent of motion in the direction of arrow 524.

A suitable bias member 526 may be associated with each cam follower 520and 522 to urge the cam followers 520 and 522 in the direction of arrow525, toward a cam surface 528 in the cover portion 504 b of the housing504. In the embodiment of FIG. 20, the bias members 526 each comprise aspring, such as, but not limited to a coil spring, bevel spring, or thelike, located between the rotor body 510 c and a respective head portion520 a or 522 a of each cam follower 520 and 522. In other embodiments,the bias members 526 may comprise one or more magnets arranged to imparta magnetic force on a magnetic material of or within each cam follower520 and 522.

In the embodiment of FIG. 20, the cam surface 528 comprises aninterior-facing surface, having portions 528 a, 528 b and 528 c,discussed above, that surrounds the opening 514 in the cover portion 504b of the housing 504. The cam surface 528 extends around thecircumference of the axis A₅ of the rotor 510 and has a first portion528 a aligned with the inlet channel 506 and a second portion 528 baligned with the outlet channel 508. The second portion 528 b of the camsurface 528 is arranged closer to the rotor body 510 c than the firstportion 528 a of the cam surface 528. For example, the second portion528 b of the cam surface 528 may be provided on a wide or thick wallsegment of the cover portion 504 b of the housing 504, relative to thewall width or thickness of the cover portion 504 b at the first portion528 a of the cam surface 528. The cam surface 528 may be a smooth,continuous surface that extends from the first portion 528 a to thesecond portion 528 b and back to the first portion 528 a, around theaxis A₅.

A flexible membrane 530 is located adjacent the surface of the rotorbody 510 c that faces the base portion 504 a of the housing 504. Theflexible membrane 530 may comprise a disk-shaped sheet of flexiblematerial, such as, but not limited to a silicone, rubber or othersuitable material, secured to one surface (the surface facing the baseportion 504 a of the housing 504) of the rotor body 510 c.

A sealing member 532 is secured to the flexible membrane 520 and rotorbody 510 c and is located between the flexible membrane 530 on the rotorbody 510 c and the base portion 504 a of the housing 504. The sealingmember 532 may be a disc-shaped plate of material that provides asuitable fluid seal and that allows rotational motion of the rotor body510 c, relative to the sealing member 530. The sealing member 532 may bemade of polytetrafluoroethylene or other suitable material that providesa relatively low friction surface facing the base portion 504 a of thehousing 504. The sealing member 532 includes a first passage 532 aarranged in alignment with one of the cam follower channels (channel 516in FIG. 20). The sealing member 532 also includes a second passage 532 barranged in alignment with the other cam follower channel (channel 518in FIG. 20). In embodiments in which the rotor body 510 c includes moreor less than two cam follower channels, the sealing member 532 includesa corresponding number of passages (e.g. passages 532 a and 532 b).

A clamp structure may be provided to provide a clamping force, forclamping the sealing member 532 between the flexible membrane 530 onrotor body 510 c and the base portion 504 a of the housing 504. In theembodiment of FIG. 20, the clamping structure comprises a plate 534attached by a screw to the free end of the end segment 510 b of therotor shaft 510 (or otherwise secured to the end segment 510 b of therotor shaft 510) and a coil spring 536 arranged between the plate 534and the base portion 504 a of the housing 504. The coil spring 536 isprovided with a suitable tension to urge the rotor in the direction ofarrow 524, relative to the housing 504.

In operation, the rotor 502 is arranged such that the end segment 510 aof the rotor shaft 510 is operatively engaged with a drive devicelocated in a durable housing portion 22 (either directly, or through asuitable linkage structure), when the disposable housing portion 20 isengaged with the durable housing portion 22, as described above. Whenoperatively engaged with the drive device, the rotor 502 (and theattached membrane 530 and sealing member 532) may be selectively rotatedaround the axis A₅ of the rotor 510, by selective activation of thedrive device.

As the rotor 502 rotates, the cam followers 520 and 522 are moved alongthe cam surface 528. The bias members 526 urge the heads 520 a and 522 aof the respective cam followers 520 and 522 against the cam surface 528.When the rotor 502 is rotated to a position at which a cam follower isaligned with the inlet channel 506 (such as the cam follower 520 inFIGS. 20 and 21), the head of that cam follower (such as the head 520 aof cam follower 520 in FIGS. 20 and 21) abuts against the first portion528 a of the cam surface 528. The first portion 528 a of the cam surface528 and the length of the cam followers 520 and 522 are selected toallow the end of the cam follower that faces the base portion 504 a ofthe housing 504 to be separated from the base portion 504 a by adistance sufficient to form an open volume 540 in the passage 532 a ofthe sealing member 532, between the flexible membrane 530 and the baseportion 504 a of the housing 504, when the head of the cam followerabuts the first portion 528 a of the cam surface 528.

Rotary motion of the rotor 502 causes the cam followers 520 and 522 tomove along the cam surface 528 and, as a result, to move in thedirection of arrow 525 as the cam follower moves from the second portion528 b, to the first portion 528 a of the cam surface 528. As the camfollower (520 in FIGS. 20 and 21) is moved in the direction of arrow525, a portion of the flexible membrane 530 that defines one side of thechamber 532 a flexes away from the base portion 504 a of the housing504, to enlarge the volume of the chamber 532 a. As the chamber 532 avolume increases, the pressure within the chamber 532 a decreasessufficient to draw a volume of fluid from a reservoir (not shown inFIGS. 20-22), through the inlet channel 506 and into the chamber 532 a.

When the rotor 502 is rotated to a position at which a cam follower isaligned with the outlet channel 506 (such as the cam follower 522 inFIGS. 20 and 22), the head of that cam follower (such as the head 522 aof cam follower 522 in FIGS. 20 and 22) abuts against the second portion528 b of the cam surface 528. The second portion 528 b of the camsurface 528 and the length of the cam followers 520 and 522 are selectedto allow the end of the cam follower that faces the base portion 504 aof the housing 504 to be relatively close to the base portion 504 a toflex a portion of the membrane toward the base portion 504 a of thehousing 504, to sufficiently close the volume in the passage 532 b ofthe sealing member 532, when the head of the cam follower abuts thesecond portion 528 b of the cam surface 528. As the chamber 532 b volumedecreases, the pressure within the chamber 532 b increases to expel thevolume of fluid from the chamber 532 b through the outlet channel 508,to the injection site (not shown in FIGS. 20-23).

Accordingly, as the rotor 502 rotates, individual volumes of fluid aredrawn in through the inlet channel 506 and into the volume of a chamber(such as chamber 532 a in FIGS. 20 and 21), moved with the rotation ofthe rotor 502 (and the membrane 530 and sealing member 532 attached tothe rotor) to align with the outlet channel 508 and expelled through theoutlet channel 508. The rotation of the rotor 502 may be controlled bycontrolling the drive device to selectively apply a rotational force tothe rotor 502, when the durable housing portion 22 and the disposablehousing portion 20 are engaged. In that manner, the drive device may beselectively driven to selectively draw volumes of fluid into the inletchannel 506 and expel volumes of fluid through the outlet channel 508.

In each of the above embodiments, the drive device and linkage structuremay comprise any suitable drive motor or other drive device and linkagethat converts electrical power to rotational motion to provide a rotarydrive force for rotating a drive shaft and/or drive gear describedabove. Such drive devices may include, but are not limited to a DCmotor, flat or pancake DC motor, servo motor, stepper motor,electronically commutated motor, rotary piezo-electrically actuatedmotor, and the like. In further embodiments, the drive device maycomprise a bender or linear actuator in combination with an escapementwheel arrangement, to rotatably drive the drive shaft and/or drive gear.For example, a drive device for rotatably driving the drive shafts ordrive gears described above may comprise a piezo-electrically actuatedbender and escapement wheel arrangement, a thermally actuated bender andescapement wheel arrangement, a shape memory alloy wire and escapementwheel arrangement, an electronically actuated solenoid and escapementwheel arrangement, or the like. Examples of shape memory alloy wiredrive systems may be found in U.S. Pat. No. 6,375,638 issued Apr. 23,2002, and entitled “Incremental Motion Pump Mechanisms Driven by ShapeMemory Alloy Wire or the Like,” and U.S. patent application Ser. No.11/230,142 filed Sep. 19, 2005, and entitled “SMA Wire Driven PositiveDisplacement MicroPump With Pulsatile Output,” both of which areincorporated herein by reference in their entirety.

Escapement wheel arrangements operable with bender or linear actuatorsin accordance with example embodiments of the present invention aredescribed with reference to FIGS. 24 a-24 c. As shown in FIG. 24 a, anescapement wheel 460 is supported for rotation around an axis A₁(extending into the page), in the direction of arrow 462. The escapementwheel 460 has an outer peripheral edge provided with serrations or teeth464. Each tooth 464 includes a sloped surface 466 arranged at an obtuseangle relative to an axial direction of the wheel 460 and a catchsurface 465 in a substantially axial direction of the wheel. A drivepawl 468 is located adjacent the escapement wheel 460 and at leastpartially between two of the teeth on the escapement wheel. The drivepawl 468 is supported for movement in a generally linear direction, asrepresented by the double arrow 469, between a start position S and anend position E.

The drive pawl 468 has a drive surface 470 for engaging the catchsurface 465 of an adjacent tooth 464 on the escapement wheel 460, whenthe drive pawl 468 is moved in a direction from the start position S tothe end position E. The drive pawl 468 has a further surface 471 facingaway from the drive surface 470 and configured for riding over thesloping surface 466 of a tooth 464 on the escapement wheel 460, when thedrive pawl is moved in a return direction from the end position E to thestart position S. The further surface 471 of the drive pawl 468 may besloped at an angle relative to the radial direction of drive wheel, toassist the drive pawl 468 in riding over the sloping surface 466 of atooth 464 of the escapement wheel.

As described in more detail below, the drive pawl 468 is coupled to abender or linear motion actuator to selectively drive the drive pawl 468from the start position S to the end position E. With each motion of thedrive pawl 468 from the start position S to the end position E, thesurface 470 engages the catch surface 465 of a tooth 464 on theescapement wheel and rotates the escapement wheel 460 a small distance.A bias member 472 is operably coupled to the drive pawl 468, to bias thedrive pawl 468 in a return direction, to return the drive pawl 468 tothe start position. The bias member 472 may comprise a spring as shownin FIG. 20 a or other suitable mechanism for providing a bias force toreturn the drive pawl 468 to the start position, including, but notlimited to a permanent magnet, electro-magnet, electronic or thermallinear actuator, shaped memory alloy, or the like. In the illustratedembodiment, the bias member 472 comprises a coil spring having one endcoupled to the drive pawl 468 and another end coupled to a fixedsurface, for example, a fixed surface of a wall or other fixed structureof or within the durable portion of the delivery devices describedabove.

A further pawl 474 may be provided to inhibit back rotation of theescapement wheel 460 in the direction opposite to the direction of arrow462. For example, the further pawl 474 may be located adjacent theescapement wheel 460 and at least partially between two of the teeth onthe escapement wheel. The further pawl 474 has a surface 476 forengaging the catch surface 465 of an adjacent tooth 464 on theescapement wheel 460, to inhibit rotary motion of the escapement wheel460 in the direction opposite to the direction of arrow 462.

The pawl 474 has a further surface 477 facing opposite to the surface476, configured for riding over the sloping surface 466 of a tooth 464on the escapement wheel 460, when the escapement wheel is driven in therotary direction of arrow 462 by action of the drive pawl 468. Thesurface 477 of the pawl 474 may be angled relative to the radialdirection of drive wheel, to assist the pawl 474 in riding over thesloping surface 466 of a tooth 464 of the escapement wheel. The pawl 474may be supported for pivotal motion about a pivot point 478 in thedirection of double arrow 479, to allow the surface 477 of the pawl 474to pivot in a direction away from the escapement wheel, to furtherassist the pawl 474 in riding over the sloping surface 466 of a tooth464 of the escapement wheel.

A bias member 480 may be arranged to bias the surface 476 of the pawl474 toward the escapement wheel, to return the pawl 474 to a position inwhich the surface 476 engages the catch surface 465 of a tooth 464,after the pawl 474 has ridden over the sloping surface 466 of anadjacent tooth 464 of the escapement wheel. The bias member 480 maycomprise a spring as shown in FIG. 24 a or other suitable mechanism forproviding a bias force to return the pawl 474 to the position in whichthe pawl surface 476 engages the catch surface 465 of a tooth 464,including, but not limited to a permanent magnet, electro-magnet,electronic or thermal linear actuator, shaped memory alloy, or the like.In the illustrated embodiment, the bias member 480 comprises a coilspring having one end coupled to the pawl 474 and another end coupled toa fixed surface, for example, a fixed surface of a wall or other fixedstructure of or within the durable portion of the delivery devicesdescribed above. In other embodiments, a spring may be located around orwithin the pivot point 478 of the pawl 474 for effecting the bias forcedescribed above.

As described above, the drive pawl 468 is coupled to a bender or linearmotion actuator to selectively drive the drive pawl 468 and cause theescapement wheel to rotate a small distance with each motion of thedrive pawl 468 from the start position S to the end position E. A benderor linear actuator may comprise a piezoelectric bender or piezoelectricactuator, a thermally actuated bender, a shape memory alloy wire, anelectronically actuated solenoid, or the like. Such actuators forproviding small, generally linear movements in response to theapplication of an electrical power signal are known. Examples of shapememory alloy wire drive systems may be found in U.S. Pat. No. 6,375,638issued Apr. 23, 2002, and entitled “Incremental Motion Pump MechanismsDriven by Shape Memory Alloy Wire or the Like,” and U.S. patentapplication Ser. No. 11/230,142 filed Sep. 19, 2005, and entitled “SMAWire Driven Positive Displacement MicroPump With Pulsatile Output,” bothof which are incorporated herein by reference in their entirety.

As shown in FIG. 24 b, a bender actuator 482 may be configured toinclude a connector end 484 that is provided with a lateral motionrepresented by arrow 486 relative to a major axis A₂ of the actuatorbody, when a power signal is applied to the actuator. Alternatively, asshown in FIG. 24 c, a linear actuator 488 may be configured to include aconnector end 492 that is provided with a longitudinal motionrepresented by arrow 494 relative to a major axis A₃ of the actuatorbody, when a power signal is applied to the actuator. A bender actuatoras shown in FIG. 24 b, for providing lateral motion, may be coupled tothe drive pawl 468 at a connection location 496. The connection location496 for a bender actuator may be on a surface of the drive pawl 468 thatis substantially perpendicular to the drive surface 470. Alternatively,a linear actuator as shown in FIG. 24 c, for providing longitudinalmotion, may be coupled to the drive pawl 468 at a connection location498. The connection location 498 for a linear actuator may be on asurface of the drive pawl 468 that is substantially parallel to thedrive surface 470. In that manner, a bender or a linear actuator asshown in FIGS. 24 b and 24 c may be employed to selectively move thedrive pawl 468 from the start position S to the end position E and, thusdrive the escapement wheel 460 in a rotary manner.

The escapement wheel 460 may be configured to rotate the rotary distanceof one tooth for each movement of the drive pawl 468 from the startposition S to the end position E. In further embodiments, the drive pawl468 may be configured to cause the escapement wheel 460 to rotate arotary distance of a pre-defined number of teeth greater than one tooth,for each movement of the drive pawl 468 from the start position S to theend position E. The escapement wheel 460 may be coupled to one of thedrive shafts or drive gears described above, to rotate the drive shaftor drive gear with rotation of the escapement wheel 460. In oneembodiment, the drive shaft may be connected in axial alignment directlyto the escapement wheel 460, such that the rotary axis A₁ of escapementwheel is in alignment with the longitudinal axis of the drive shaft. Inother embodiments, the escapement wheel 460 may be coupled, in axialalignment, with any one of the drive gears described above, to transferrotary motion of the escapement wheel 460 to the drive gear. In yetfurther embodiments, other suitable gear and linkage arrangements may beemployed for transferring rotary motion of the escapement wheel 460 tothe drive shaft or drive gear.

The use of bender or linear actuators with escapement wheel arrangementsas described above may provide certain advantages over electric motorand linkage arrangements, in that the bender or linear actuators canprovide a repeatable, controlled, step-like response to an electricalpower signal. In the context of driving a delivery device for deliveringa medication to a patient-user, the ability to accurately control thedrive response can provide significant advantages, for example, inadministering accurate quantities, small quantities at accurate levelsand accurate recording of delivered quantities of the medication. Inaddition, bender or linear actuators with escapement wheel arrangementscan be made relatively small and flat and can, therefore, improve theability to form the delivery device with a relatively small and flatshape. In addition, bender or linear actuators with escapement wheelarrangements can operate with relatively low power requirements, thusprolonging the operational life of the power source and allowing smallerpower sources to be employed, thus, allowing further reductions in thesize of the delivery device.

Other types of drive devices may be coupled to an escapement wheel 460,through a single tooth wheel 499, as shown in FIG. 24 d, to provide acontrolled, step-like response. For example, in the embodiment shown inFIG. 24 d, the escapement wheel 460 may be coupled to the drive shaftsor drive gears described above, while the single tooth wheel 499 may becoupled to be driven by any suitable rotary drive source, including, butnot limited to a DC motor, flat or pancake DC motor, servo motor,stepper motor, electronically commutated motor, rotarypiezo-electrically actuated motor, and the like. While the wheel 499 inFIG. 24 d is provided with a single tooth to effect a rotation of theescapement wheel 460 a rotary distance of a single tooth for eachcomplete rotation of the wheel 499, other embodiments may employ a wheel499 having two teeth (or another pre-defined number of teeth) foreffecting a rotation of the escapement wheel 460 a rotary distance oftwo teeth (or the pre-defined number of teeth) for each completerotation of the wheel 499.

In embodiments described above, the disposable housing portion (e.g., 20in FIG. 3) is provided with a base portion 21 that may be secured to thepatient-user's skin by, for example, but not limited to, an adhesivematerial provided on the bottom surface of the base portion 21. Thatarrangement is generally represented, in side view, in FIG. 25, whereinan adhesive material 101 is provided on the bottom surface (skin-facingsurface) of the base 21 of the disposable housing portion 20. As shownin FIGS. 2, 3 and 25, the durable housing portion 22 may be configure tobe arranged on the base 21 of the disposable housing portion 20 toengage and connect to the disposable housing portion 22. In such anarrangement, the base 21 may be disposed between the durable housingportion 22 and the patient-user's skin, during operation, such that onlythe base 21 of the disposable housing portion remains in contact withthe patient-user's skin, during operation.

However, in other embodiments, the durable housing portion 22 and thedisposable housing portion 20 may be configured to engage each other ina side-by-side arrangement, for example, as represented in FIG. 26. Inthe side-by-side arrangement in FIG. 26, either one or both of thedurable housing portion 22 and the disposable housing portion 20 may beprovided with a base having an adhesive material 101 (and a peelablecover layer 23 as shown in FIG. 3).

In yet further embodiments, as represented by FIG. 27, one or both ofthe durable housing portion 22 and the disposable housing portion 20 maybe attachable and detachable from a separate base member 21′. Suitableconnecting structure, such as described above for connecting the durablehousing portion and the disposable housing portion together, may beemployed for connecting the durable housing portion and the disposablehousing portion to the base member 21′. The separate base member 21′ mayinclude a generally flat, plate-like structure made of any suitablyrigid material including, but not limited to, plastic, metal, ceramic,composite material or the like. The base member 21′ has a surface (theupper-facing surface in FIG. 25) to which the disposable housing portion20 and the durable housing portion 22 may be attached. The base member21′ has a second surface (the lower-facing surface in FIG. 27) to whichan adhesive material and a peelable cover film may be applied, asdescribed above, to allow the base member 21′ to be secured to apatient-user's skin.

The base member 21′ may include a needle inserter device 25, asdescribed above. Examples of suitable needle inserter devices aredescribed in U.S. patent application Ser. No. 11/211,095, filed Aug. 23,2005, and U.S. Patent Application No. 60/839,840, titled “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device Method”, filed Aug. 23, 2006, (attorney docketno. 047711-0384), each of which is incorporated herein by reference inits entirety. In such embodiments, the base member 21′ may be secured toa patient-user's skin. Then, the needle inserter 25 may be activated toinsert a hollow needle or cannula into the patient-user's skin. Then,after the hollow needle or cannula is inserted, the durable housingportion 22 and the disposable housing portion 20 may be attached to thebase member 21′, to connect the reservoir within the disposable housingportion 20 in fluid flow communication with the hollow needle orcannula. In one embodiment, the durable housing portion 22 and thedisposable housing portion 20 may be connected together (for example, inthe manner described above) before attaching those housing portions tothe base member 21′. In a further embodiment, one of the durable anddisposable housing portion is attached to the base member 21′ before thedurable and disposable housing portions are connected together. In suchfurther embodiment, the needle inserter device may be activated toinsert a hollow needle or cannula into the patient-user's skin after thedisposable housing portion is attached to the base member 21′ (eitherbefore or after the durable and disposable housing portions areconnected together). Other needle/cannula insertion tools may be used(or modified for use) to insert a needle and/or cannula, such as forexample U.S. patent application Ser. No. 10/389,132 filed Mar. 14, 2003,and entitled “Auto Insertion Device For Silhouette Or Similar Products,”and/or U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002,and entitled “Insertion Device For Insertion Set and Method of Using theSame,” both of which are incorporated herein by reference in theirentirety.

Alternatively, reference number 25 may represent an opening in the basemember 21′ that aligns with a needle inserter device (or aligns with afurther opening) located in the disposable housing portion 20, when thedisposable housing portion 20 is attached to the base member 21′. Insuch embodiments, the base member 21′ may be secured to thepatient-user's skin. Then the disposable housing portion 20 is attachedto the base member 21′ (either before or after the durable anddisposable housing portions are connected together). Once the disposablehousing portion 20 is attached to the base member 21′, the needleinserter device 25 may be activated to insert a hollow needle or cannulainto a patient-user's skin (either before or after the durable anddisposable housing portions are connected together).

Also, while embodiments described above may include an on-board needleor cannula injector device that may be activated through the operator oropening 25, other embodiments may employ an injection site module 103that is external to the disposable housing portion 20, but connected tothe disposable housing portion 20, through a suitable conduit 102, asshown in FIG. 28. The external injection site module 103 may include aneedle or cannula injector device structure and an operator or opening(similar to the operator or opening 25 described above) through whichthe injector device may be activated. Alternatively or in addition, theexternal injection site module 103 may include an infusion set such as,but not limited to an infusion set as described or referenced in U.S.patent application Ser. No. 10/705,686, filed Nov. 10, 2003, titled“Subcutaneous Infusion Set” (Publication No. 2005/0101910) and/or U.S.patent application Ser. No. 11/004,594, filed Dec. 3, 2004, titled“Multi-Position Infusion Set Device And Process” (Publication No.2006/0129090), each of which is assigned to the assignee of the presentinvention and each of which is incorporated herein by reference, in itsentirety.

The conduit 102 that connects the module 103 with the disposable housingportion 20 may be any suitable tubing structure having a fluid flowpassage, such as, but not limited to, a flexible tube made of plastic,silicone or the like. An adhesive material may be provided on the tubingstructure (or between the tubing structure and the patient-user's skin)to secure the tubing to the patient-user's skin. By locating theinjection site module 103 external to the disposable housing portion 20,the disposable housing portion 20 and the durable housing portion 22 maybe clipped to a patient-user's clothing, belt, suspender or otherarticle of apparel or may be held in a pocket of an article of apparelor carried in a purse or the like.

In one embodiment, the conduit 102 may be fixed at one end to thedisposable housing portion 20, in fluid-flow communication with thereservoir within the disposable housing portion 20, and fixed at asecond end to an external injection site module 103, for connection influid-flow communication with a hollow needle or cannula, as describedabove. In further embodiments, one or both of the ends of the conduit102 may include suitable connection structures that allow the conduitends to be selectively connected in fluid-flow communication with, andselectively disconnected from the disposable housing portion 20 and/orthe injection site module 103. Such connectors may comprise a hollowneedle and septum, a Luer connector, or other suitablefluid-communication connectors. In such embodiments, the disposablehousing portion 20 and the durable housing portion 22 may bedisconnected from the module 103, for example, by disconnecting one ofthe ends of the conduit 102 from the module 103 or the disposablehousing portion 20, while leaving the module 103 in place (withoutrequiring the patient-user to withdraw the needle or cannula and, later,insert a needle or cannula to resume operation). In this manner, apatient-user may readily disconnect and remove the disposable housingportion 20 and durable housing portion 22, for example, to allow thepatient-user to shower, bath, swim or conduct other activities, yet alsoallow the patient-user to readily re-connect the disposable housingportion 20 to the module 103, for example, upon completion of suchactivities. Examples of connectors can be found in U.S. patentapplication Ser. No. 10/328,393 filed Dec. 22, 2003, and entitled“Reservoir Connector,” and U.S. Pat. No. 5,545,152 issued Aug. 13, 1996,and entitled “Quick-Connect Coupling For A Medication Infusion System,”both of which are incorporated herein by reference in their entirety. Inother alternatives, different connectors such as Luer locks, or the likemay be used.

In yet further embodiments, the conduit 102 may be eliminated and aninjection site module 103 may be directly connected with the disposablehousing portion 20, as shown in FIG. 29. In such an embodiment, one ormore suitable fluid flow passages are provided through the disposablehousing portion 20 and into the injection site module 103, forfluid-flow communication between the reservoir in the disposable housingportion 20 and a hollow needle or cannula, as described above. Also, insuch embodiments, the injection site module 103 and the disposablehousing portion 20 may include mating connection structures to allow theinjection site module 103 and the disposable housing portion 20 to beselectively connected and disconnected from each other.

Various examples of mating arrangements, for directly connecting aninjection site module 103 to a disposable housing portion are describedwith reference to FIGS. 30-37. FIGS. 30-32 show an example arrangement,in which an injection site module 103 includes at least one (two in FIG.26) protruding engagement pawl 174 that are configured to be received ina corresponding number of receptacles on the disposable housing portion20 (similar to the pawls 74 and receptacles 76 described in U.S. PatentApplication No. 60/839,741, titled “Infusion Pumps And Methods AndDelivery Devices And Methods With Same”, filed Aug. 23, 2006, (attorneydocket no. 047711-0385), which has been incorporated herein byreference. In other embodiments, the pawl(s) 174 may be located on thedisposable housing portion 20, while the corresponding receptacles maybe located on the module 103. In yet other embodiments, each of thedisposable housing portion 20 and the module 103 may include one or morepawls and one or more receptacles.

The pawls 174 and receptacles may be configured to allow a patient-userto manually slide the pawls into the receptacles as the disposablehousing portion 20 and the module 103 are brought together. When thepawls 174 are received in the corresponding receptacles, the module 103is secured to the disposable housing portion 20. The pawls 174 mayinclude a shaped portion or head to provide a snap-fit with thereceptacles, when the pawls 174 are fully received within thereceptacles. The pawls 174 may be configured with sufficient flexibilityto allow the patient-user to separate the disposable housing portion 20from the module 103, by applying a sufficient force to full those twoparts away from each other and unsnap the pawls 174 from thereceptacles. In the embodiment of FIGS. 30-32, the module 103 may beattached to or may include a base portion 450 that may be secured to apatient-user's skin during operation, in lieu of the extended base 21 ofthe disposable housing portion 20 described above. The base portion 450may include an adhesive material as described herein with respect to thebase 21 of the disposable housing portion 20.

As shown in FIG. 32, the embodiment of FIGS. 30-32 may be formed inthree general parts, including the disposable housing portion 20, thedurable housing portion 22 and the module 103 on the base portion 450.The durable housing portion 22 and the disposable housing portion 20 maybe secured together (as shown in FIG. 28), and the combined, connecteddisposable and durable housing portions may be secured to the module 103and base portion 450. In one embodiment, the base portion 450 may besecured to a patient-user's skin, before the combined, connecteddisposable and durable housing portions are secured to the module 103and base portion 450. In a further embodiment, the combined, connecteddisposable and durable housing portions are secured to the module 103and base portion 450, before the base portion 450 is secured to thepatient-user's skin.

Another example of a connection structure is described with reference toFIGS. 33 and 34, wherein the module 103 includes a shaped head 452configured to be received within a correspondingly shaped opening orreceptacle in the disposable housing portion 20. The shaped head 452 maybe configured with a shape that allows the head to be received in thereceptacle when the disposable housing portion 20 is aligned relative tothe module 103 in a first alignment position, as shown in FIG. 29, andfurther allows the disposable housing portion 20 to be rotated relativeto the module 103 while the head 452 is received within the receptacleto a second alignment position as shown in FIG. 34. The receptacle inthe disposable housing portion 20 may be shaped to allow the head 452 tobe freely received or removed from the receptacle, when the disposablehousing portion 20 is in the first alignment position (FIG. 33), yetabut the head 452 and inhibit separation of the head 452 from thereceptacle (and, thus, inhibit separation of the disposable housingportion 20 from the module 103), when the disposable housing portion isin the second alignment position (FIG. 34).

A further example of a connection structure is described with referenceto FIGS. 35-37, wherein the module 103 includes a shaped receptacle 454configured to receive a correspondingly shaped connector member in thedisposable housing portion 20. In FIGS. 35-37, the module 103 is formed,integral with the disposable housing portion 20. The shaped receptacle454 may be configured with a shape that allows the connector member ofthe disposable housing portion to be engaged with the receptacle 454when the disposable housing portion 20 is aligned relative to the module103 in a first alignment position, as shown in FIG. 35, and furtherallows the disposable housing portion 20 to be rotated relative to themodule 103, while the receptacle 454 is engaged within the connectormember, to a second alignment position as shown in FIG. 36. Thereceptacle 454 and the connector member in the disposable housingportion 20 may be shaped to allow the connector member to be freelyengage the receptacle 454, when the disposable housing portion 20 is inthe first alignment position (FIG. 35), yet lock with the receptacle 454and inhibit separation of the connector member from the receptacle (and,thus, inhibit separation of the disposable housing portion 20 from themodule 103), when the disposable housing portion is in the secondalignment position (FIG. 36). The receptacle 454 and connection membermay include any suitable known rotary connection structures forconnecting two structures together upon engagement and relative rotationof the two structures in one direction, yet allow the two structures tobe disengaged and separated from an engaged arrangement, by relativerotation of the two structures in the second, opposite direction.

As shown in FIG. 37, the embodiment of FIGS. 35-37 may be formed inthree general parts, including the disposable housing portion 20, thedurable housing portion 22 and the module 103 on the base portion 456.The durable housing portion 22 and the disposable housing portion 20 maybe secured together (as shown in FIG. 35), and the combined, connecteddisposable and durable housing portions may be secured to the baseportion 456. In one embodiment, the base portion 456 may be secured to apatient-user's skin, before the combined, connected disposable anddurable housing portions are secured to the base portion 456. In afurther embodiment, the combined, connected disposable and durablehousing portions are secured to the base portion 456, before the baseportion 456 is secured to the patient-user's skin.

In yet further embodiments, the injection site module may be formed as aunitary structure with the disposable housing portion 20. Also, in anyof the embodiments described above, one or more sensors may be locatedin the disposable housing portion 20, the injection site module 103 orthe durable housing portion 22, for sensing a biological condition,including, but not limited to, blood glucose level, level of infusionmedium in the patient-user's blood and/or other conditions. Suchsensor(s) may include a hollow needle or cannula and/or a set ofmicro-needles, as described above, for piercing the patient-user's skinto convey fluid from the patient to the sensor.

Various aspects of the multiple embodiments described above may beemployed independently or in combinations thereof. Significantadvantages can be obtained from various embodiments and combinationsdescribed herein, wherein an at-site delivery system may be made of twoparts, including a disposable portion and a non-disposable portion. Thedisposable portion may contain all materials that are in direct contactwith the infusion medium, such as reservoir body, reservoir piston,septum systems and injection needle. The non-disposable portion couldcontain substantially the materials that are not in contact with themedication including the drive system, pressure or force sensing system,battery, electronics, display, and non-disposable housing. The pumpcould be designed such that the disposable portion (user filled orpre-filled cartridge) is inserted into the non-disposable portion. Bysimplifying the manner in which the disposable portion of the deliverydevice can be replaced and by simplifying the manner in which thedelivery device can be re-activated after replacing a disposableportion, a greater number of patient-users will be able to use andbenefit from such delivery devices.

While particular embodiments of the present invention have been shownand described, it will be obvious to those skilled in the art that theinvention is not limited to the particular embodiments shown anddescribed and that changes and modifications may be made withoutdeparting from the spirit and scope of the claimed invention. Forexample, while embodiments described above may include an adhesivematerial and a cover film 23 (FIGS. 2 and 3), further embodiments mayinclude a plurality of adhesive material layers alternating with acorresponding plurality of cover film layers 23, to allow the deliverydevice to be secured, removed and re-secured to the patient-user's skinone or more times.

In such embodiments, a first cover film layer located at the end of thestack of alternating layers of adhesive material and cover film, may beremoved to expose a first layer of adhesive material. With the firstlayer of adhesive material exposed, the delivery device (or componentthereof) may be adhered to a patient-user's skin, as described above.After a suitable period of usage, the delivery device (or componenthaving the adhesive) may be removed from the patient-user's skin, forexample, for servicing, re-filling, replacement of one or morecomponents, or the like. After removal of the delivery device (orcomponent) from the patient-user's skin, a second cover film layer onthe delivery device (or component) may be removed to expose a secondlayer of adhesive material. With the second layer of adhesive materialexposed, the delivery device (or component) may be secured to the samepatient-user or, in certain contexts, to a different patient-user, forfurther operation. The process may be repeated a number of times up tothe number of adhesive material and cover film layer pairs are includedin the plural alternating layers of adhesive material and cover film.

In addition, while embodiments described above include an injection sitelocated on the disposable housing portion 20 or in an external injectionsite module 103, other embodiments may employ an injection site locatedin the durable housing portion 22 and connected, through suitablefluid-flow passages, to the reservoir in the disposable housing portion20, when the durable housing portion and disposable housing portion areengaged. Also, while embodiments are described above in the context ofdelivery devices for delivering an infusion medium from a reservoir to apatient-user, other embodiments may be operated to withdraw a fluidicmedium from a patient-user (or other source) and transfer the fluidicmedium to the reservoir. Such other embodiments may be operated byoperating the drive device to selectively move the piston plunger awayfrom the septum-end of the reservoir (to increase the fluid-retainingvolume of the reservoir) to create a negative pressure sufficient todraw fluid from the patient-user (or other source) to which the hollowneedle or cannula is secured.

Also, various embodiments described above may employ a reservoir that,in some examples, may comprise a canister that is removable from andinsertable into the first or disposable housing portion. In this manner,a reservoir cartridge may be removed and replaced with a new,refurbished, user-filled, prefilled, refilled or re-manufacturedcartridge. In such embodiments, the reservoir cartridge may include anelectronic storage device (such as an electronic memory chip or thelike) for storing information, such as, but not limited to,identification of the contents of the reservoir, identification of themaker of the reservoir or its contents, information relating to thestate of fill or depletion of the reservoir, or the like. Suitableelectrical contact pads located in the disposable housing portion mayelectrically connect with contact pads on the reservoir, to electricallyconnect the electronic storage device on the reservoir canister withsuitable electronics in the disposable housing portion or the durablehousing portion, for reading information stored on the electronicstorage device. Such information (or other information, warnings, etc.,associated with the stored information) may be displayed on a displaydevice on the durable housing portion, when the reservoir canister isinserted into the disposable housing portion, and the disposable housingportion and the durable housing portion are engaged.

In addition, in any of the above-described embodiments, one or both ofthe disposable housing portion and the durable housing portion (and/or aseparate base portion or a separate injection site module) may include aforce sensor (not shown) or other suitable sensing device for sensingthe proper placement or engagement of one or more of the disposablehousing portion and the durable housing portion (and/or a separate baseportion or a separate injection site module) on a patient-user's skin(or other proper location for operation with the patient). In such anembodiment, further electronics may control the operation of the drivedevice to inhibit operation of the drive device and/or the needleinjector, unless the sensor senses the proper operable engagement of oneor more of the disposable housing portion and the durable housingportion (and/or a separate base portion or a separate injection sitemodule) with the patient-user's skin (or other proper location foroperation).

Alternatively or in addition, one or both of the disposable housingportion and the durable housing portion may include a sensing device(not shown) for sensing the proper operable engagement of the disposablehousing portion and the durable housing portion together (and/or with aseparate base portion or a separate injection site module). In such anembodiment, further electronics may control the operation of the drivedevice to inhibit operation of the drive device and/or the needleinjector, unless the sensor senses the proper operable engagement of thedisposable housing portion and the durable housing portion together(and/or with a separate base portion or a separate injection sitemodule).

In any of the above embodiments, a sensor may be provided in (orotherwise associated with) the reservoir to detect a low volume ofinfusion medium in the reservoir. For example, a sensor may beconfigured to detect a condition at which the volume of infusion mediumin the reservoir reaches a threshold minimal level. A warning device maybe operably connected to the sensor, to provide a warning signal, uponthe detection of a low volume condition. The warning device may providean audible warning sound, a visible warning signal and/or a tactilewarning signal (such as, but not limited to a perceptible vibration) tothe patient-user, upon the detection of the volume of infusion medium inthe reservoir reaching a threshold minimal level. In one embodiment, thevisible warning may be provided as a message on an electronic display(as described above) on the durable housing portion. Alternatively or inaddition, a warning signal condition may be communicated to anddisplayed on a remote CCD 16 or computer 18 (FIG. 2), for example,through wireless communication electronics as described above.

In addition, while various embodiments described above may include oneor more adhesive layers, each having a peelable cover layer, otherembodiments may employ a single adhesive layer having (or pluraladhesive layers, each having) a pattern of plural peelable cover layerportions, such that a patient-user may peel off one portion of the coverlayer for adhering the delivery device to the patient-user as describedabove, while leaving the rest of the pattern of peelable cover layerportions on the adhesive. In such an embodiment, after completion of afirst period of operation of the delivery device and removal of thedelivery device from the patient-user, a second portion of the peelablecover layer may be removed from the adhesive layer and the deliverydevice may be adhered to a patient-user for a second period ofoperation.

Also, while various delivery device embodiments described above includebase portions that are configured to be secured to a patient-user's skin(or other suitable surface of operation) and that extend along the fulllength and width of the delivery device structure, other embodiments mayemploy base portions (that secure to the patient-user's skin or othersurface) that are configured to be less than the full length or widthdimension of the delivery device structure, to minimize the surface areain contact with the patient-user (or other surface) and, thus, improvepatient-user comfort during operation. Base portions having shapes andsizes different from those shown in the accompanying drawings may beemployed for additional improvements with regard to patient-user comfortand minimizing surface area in contact with the patient-user.Furthermore, as noted above, the base portion may be composed of aflexible material that at least partially conforms to the curvature andmovement of the patient-user's body.

In any of the above-described embodiments in which an adhesive materialis used to secure one or more of the delivery device components to thepatient-user's skin (or other suitable surface for operation), multipletypes of adhesive materials (or multiple strengths of adhesives) may beemployed, such that a stronger adhesive is provided in certain areas(such as around the needle injection site), while a weaker adhesive isprovided in other areas.

1. A delivery device comprising: a first housing portion; a secondhousing portion configured to selectively engage with and disengage fromthe first housing portion; a compressible reservoir located in the firsthousing portion, the reservoir having an interior volume for containinga fluid, the reservoir having an outlet connectable in fluid flowcommunication with an injection site, the interior volume of thereservoir being compressible to reduce the interior volume and increasefluid pressure within the interior volume to drive fluid from theinterior volume to the injection site; a compression mechanism operableon the reservoir a drive device supported by the second housing portionand operatively connectable to at least one of the reservoir and thecompression mechanism when the first and second housing portions areengaged, to selectively cause relative movement between the reservoirand compression mechanism for selective compression of the reservoir. 2.A delivery device according to claim 1, further comprising a moveabletrack operatively coupled to the drive device to be selectively movedalong a track path and wherein the compression mechanism comprises atleast one roller or pad supported by the moveable track for engaging andcompressing the reservoir as the track is moved along the track path. 3.A delivery device according to claim 1, further comprising a moveabletrack operatively coupled to the drive device to be selectively movedalong a track path, the moveable track being connected to the reservoirto move the reservoir as the track is moved along the track path, andwherein the compression mechanism comprises a pair of compressionsurfaces between which a portion of the reservoir is moved as the trackis moved along the track path, the compression surfaces imparting acompression force on the reservoir as the portion of the reservoir ismoved between the compression surfaces.
 4. A delivery device accordingto claim 3, wherein the pair of compression surfaces comprise a pair ofrollers.
 5. A delivery device according to claim 1, wherein thecompression mechanism comprises a plunger head supported for movementwithin the interior volume of the reservoir, the delivery device furthercomprising a moveable track operatively coupled to the drive device tobe selectively moved along a track path, the moveable track beingoperatively connectable to the plunger head to move the plunger headwithin the reservoir when the track is moved along the track path andwhen the first and second housing portions are engaged.
 6. A deliverydevice according to claim 5, wherein the reservoir comprises a curvedchannel having a radius of curvature and wherein the track has a radiusof curvature approximating the radius of curvature of the curvedchannel.
 7. A delivery device according to claim 1, further comprisingelectrical control circuitry contained in the second housing portion,wherein the electrical control circuitry controls the drive device fordelivery of infusion media from the reservoir to the user when thesecond housing portion and the first housing portion are engaged.
 8. Adelivery device according to claim 1, wherein one of the first andsecond housing portions comprises a base portion having a bottom surfaceand an adhesive material on the bottom surface for securing that housingportion to the skin of the user.
 9. A delivery device according to claim1, further comprising a moveable track coupled to one of the compressionmechanism or the reservoir, wherein the drive device is operativelycoupled to the moveable track for moving the moveable track and one ofthe compression mechanism or the reservoir relative to the other of thecompression mechanism and reservoir.
 10. A delivery device according toclaim 9, further comprising linkage structure for operatively couplingthe drive device to the moveable track, to transfer drive force from thedrive device to the moveable track.
 11. A method of making a deliverydevice, the method comprising: providing a first housing portion;providing a second housing portion configured to selectively engage withand disengage from the first housing portion; supporting a compressiblereservoir on the first housing portion, the reservoir having an interiorvolume for containing a fluid and an outlet connectable in fluid flowcommunication with an injection site, the reservoir being compressibleto reduce the interior volume and increase fluid pressure within theinterior volume to drive fluid from the interior volume to the injectionsite; supporting a compression mechanism in a position to selectivelycompress the reservoir; supporting a drive device supported on thesecond housing portion in a position to operatively connect to at leastone of the reservoir and the compression mechanism when the first andsecond housing portions are engaged, to selectively cause relativemovement between the reservoir and compression mechanism for selectivecompression of the reservoir.
 12. A method according to claim 11,further comprising operatively coupling a moveable track to the drivedevice to be selectively moved along a track path and wherein supportinga compression mechanism comprises supporting at least one roller or padon the moveable track for engaging and compressing the reservoir as thetrack is moved along the track path.
 13. A method according to claim 11,further comprising: operatively coupling a moveable track to the drivedevice to be selectively moved along a track path; and connecting themoveable track to the reservoir to move the reservoir as the track ismoved along the track path; wherein supporting a compression mechanismcomprises supporting a pair of compression surfaces between which aportion of the reservoir is moved as the track is moved along the trackpath, the compression surfaces supported in a position to impart acompression force on the reservoir as the portion of the reservoir ismoved between the compression surfaces.
 14. A method according to claim13, wherein supporting a pair of compression surfaces comprisesupporting a pair of rollers on the first housing portion.
 15. A methodaccording to claim 11, wherein supporting a compression mechanismcomprises supporting a plunger head for movement within the interiorvolume of the reservoir, the method further comprising operativelycoupling a moveable track to the drive device to be selectively movedalong a track path and operatively coupling the moveable track to theplunger head to move the plunger head within the reservoir when thetrack is moved along the track path and when the first and secondhousing portions are engaged.
 16. A method according to claim 15,wherein the reservoir comprises a curved channel having a radius ofcurvature and wherein the track has a radius of curvature approximatingthe radius of curvature of the curved channel.
 17. A method according toclaim 11, further comprising containing electrical control circuitry inthe second housing portion, wherein the electrical control circuitrycontrols the drive device for delivery of infusion media from thereservoir to the user when the second housing portion and the firsthousing portion are engaged.
 18. A method according to claim 11, whereinproviding a first housing portion and providing a second housing portioncomprises providing one of the first and second housing portions with abase portion having a bottom surface and an adhesive material on thebottom surface for securing that housing portion to the skin of theuser.
 19. A method according to claim 11, further comprising operativelycoupling a moveable track to one of the compression mechanism or thereservoir and operatively coupling the drive device to the moveabletrack for moving the moveable track and one of the compression mechanismor the reservoir relative to the other of the compression mechanism andreservoir.
 20. A method according to claim 19, further comprisingoperatively coupling linkage structure to the drive device and to themoveable track, to transfer drive force from the drive device to themoveable track.